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CLIA Related Federal Register
[Federal Register: May 15, 1995 (Volume 60, Number 93)]
[Notices ]
[Page 25943-25976]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15my95-101]
[[Page 25943]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Public Health Service
_______________________________________________________________________
Specific List for Categorization of Laboratory Test Systems, Assays,
and Examinations by Complexity; Notice
[[Page 25944]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Specific List for Categorization of Laboratory Test Systems,
Assays, and Examinations by Complexity
agency: Public Health Service, HHS.
action: Notice with comment period.
-----------------------------------------------------------------------
summary: Regulations codified at 42 CFR 493.17, implementing the
Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law
100-578, require that the Secretary provide for the categorization of
specific laboratory test systems, assays, and examinations by level of
complexity. The criteria for such categorizations also are set forth in
those regulations.
A compiled list of approximately 12,000 specific clinical
laboratory test systems, assays, and examinations categorized by level
of complexity was published in the Federal Register on July 26, 1993
(58 FR 39860). This notice contains responses to the comments submitted
on those aspects of the July 26, 1993 publication that were subject to
comment. This Notice also announces approximately 2900 additional test
systems, assays, and examinations that have been categorized since the
publication of the compiled test list. Included in this list of
additional categorizations are those test systems which received 510(k)
or premarket approval from the Food and Drug Administration (FDA)
during the period from September 1, 1992 to March 15, 1995. Also
included are additional test systems that were cleared prior to that
period and noted by commenters as missing from the compiled test list.
dates: Effective date: The categorizations on this list were effective
on the date of the test categorization notification letter sent to the
manufacturer. Written comments on the tests initially categorized in
this Notice will be considered if they are received at the address
indicated below, by no later than 5 p.m. on June 14, 1995. CDC reserves
the right to reevaluate and recategorize tests based on the comments
received in response to this Notice.
addresses: Comments on the categorization of tests initially
categorized in this Notice should be addressed to Public Health
Service, Attention: CLIA Federal Register Notice, Centers for Disease
Control and Prevention, Mail Stop F-11, 4770 Buford Highway, NE.,
Atlanta, Georgia 30341-3724.
Due to staffing and resource limitations, we cannot accept
facsimile (FAX) copies of comments. Nor can we accept comments by
telephone.
for further information contact: Rosemary C. Bakes-Martin, (404) 488-
7655.
supplementary information: All requests for recategorization received
during the 30 day comment period provided in the July 26, 1993 Federal
Register notice (59 FR 39860) resulted in extensive review of available
product information and the original complexity scoring for the
individual test system, assay, or examination under consideration. If
the requestor submitted new information, the test system was rescored
taking into account the new information. Any changes in categorization
or reasons for not making changes are addressed in this Notice under
the section Comments and Responses.
Comments in response to the July 26, 1993 Notice, that requested
additional laboratory tests be waived of specific CLIA requirements,
were deferred in light of the moratorium declared on classifying
testing devices as waived tests on February 18, 1993. The CDC lifted
the moratorium on waiver on December 19, 1994, and has now resumed
reviewing requests for waiver status. On the date that the moratorium
was lifted, a letter was sent to manufacturers of laboratory testing
devices, that included guidelines that manufacturers may use to submit
their requests for waiver. Requests for waiver will be evaluated in the
order in which they are received.
The public has requested that test categorization information be
made available electronically. CDC is providing computer access to this
information via the Internet. For further information regarding this
capability, please call (404) 488-7655.
Comments and Responses
Comment: A manufacturer requested clarification of what determines
whether a testing device is subject to CLIA regulations. The commenter
had concerns about measuring versus monitoring devices and ``in-vitro''
versus ``in-vivo'' testing.
Response: All clinical laboratory tests performed on materials
derived from the human body for the purpose of providing information
for the diagnosis, prevention, or treatment of any disease, or the
assessment of the health of, human beings are subject to CLIA
regulations. The term ``derived from the human body'' refers to any
specimen that is expelled from the human body, withdrawn by procedures
such as phlebotomy, or, in the case of blood, diverted from the
circulatory path. The circulatory path is defined as either the body's
normal circulatory blood flow or a path established by a life-
sustaining apparatus such as the ``heart-lung'' machine. To be
considered as a normal circulatory path, the ``heart-lung'' machine
blood flow must be for the purpose of sustaining life and not for the
purpose of performing testing. The examination of materials removed or
diverted from either of these circulatory paths (normal or life
sustaining) meets the definition of ``in-vitro'' testing and is subject
to the CLIA regulations. An example of this type of procedure is ``ex-
vivo'' blood gas testing performed on a specimen diverted or removed by
means of an indwelling radial catheter. (This indwelling catheter has
not been established for the purpose of sustaining life and is outside
the circulatory flow.) All tests that meet the definition of ``in-
vitro'' testing are subject to CLIA regulations. ``In-vivo'' testing,
i.e. testing that is not removed or diverted from a normal or life
sustaining circulatory path, is not subject to CLIA regulation at the
present time. An example of this type of testing is pulse oximetry.
Please note, however, that we are presently investigating the
definitional and technical issues, and necessary revisions to the
regulations that would make ``in-vivo'' testing subject to CLIA. Should
it be determined at a later date that it is subject to CLIA, proper
notice and opportunity for public comment will be provided before this
testing is subject to CLIA regulation.
The context in which the test results are being evaluated, i.e.
monitoring versus measurement, is not a consideration for test
complexity.
Comment: A few manufacturers commented that some of their test
systems should not be categorized for certain analytes because the
company did not supply the reagents for performing these tests on the
instruments listed.
Response: Although the company which manufactures a test system may
not have developed an assay procedure for a particular analyte, it is
quite possible that another company could design an assay procedure
that has been cleared by the FDA for use on the test system. In such a
situation, the analyte will be listed as being available on the test
system. If the assay developed by the reagent manufacturer does not
perform as it should on the test system, it is the responsibility of
the laboratory performing the testing or the manufacturer of the test
system to inform the FDA.
[[Page 25945]]
Comment: Abbott Laboratories commented that the compiled list
published on July 26, 1993 in the Federal Register did not specifically
state whether the analytes Toxoplasma gondii Antibodies,
Cytomegalovirus Antibodies, and Rubella Antibodies on the Abbott IMX
were for determining IgG, IgM, or total antibodies.
Response: The analyte nomenclature for antibodies to
cytomegalovirus, toxoplasmosis, and rubella does not specify that the
antibodies are total, IgG, or IgM antibodies. In those instances where
a kit is used to identify the antibodies, the test system name will
frequently specify that the antibodies being detected are either total
antibodies, or IgG or IgM specific antibodies. When the test system
name does not include the specific antibody, as is the case with the
automated analyzers, then the generic nomenclature for the antibody can
refer to total or specific antibodies. We do not see this nomenclature
as a problem because the test complexity for the procedure will be the
same regardless of whether the antibodies being detected are total are
specific antibodies.
Comment: One organization, after learning of the recommendation by
the Clinical Laboratory Improvement Advisory Committee (CLIAC) and
subsequent move of some HDL procedures from high to moderate
complexity, requested recategorization of HDL procedures back to high
complexity. The organization felt that all HDL procedures should
receive a complexity score of ``3'' for the criteria ``Training and
Experience'' and ``Calibration, Quality Control or Proficiency Testing
Materials.'' Another manufacturer requested that numerous HDL
procedures be recategorized from high complexity to moderate
complexity. Other commenters indicated that based upon the process for
recategorization of 16 HDL procedures from high to moderate complexity
announced in the July 26, 1993 Notice, there were some inconsistencies
in the application of this process to other HDL procedures. The
commenters felt that the reagent preparation requirements for some of
the HDL procedures that remained high complexity were not sufficiently
complicated to warrant a higher score than those HDL procedures that
were recategorized to moderate complexity. The commenters requested
that the scores of these HDL procedures be lowered from ``2'' to ``1''
in the criterion ``Reagents and Materials Preparation'' and that these
procedures be recategorized from high complexity to moderate
complexity.
Response: In response to the continuing concerns regarding the
categorization of HDL cholesterol, CDC once again reassessed the
assigned scores for HDL as performed by automated methods. The original
CLIAC discussion had focused on the question of the training and
experience, and interpretation and judgment necessary for the analyst
to make appropriate decisions (e.g., evaluation of the supernatant's
turbidity in the pretreatment precipitation step) during the testing
process. It was on this issue that CDC determined that analyst
interaction was of a lesser degree for some automated methods than for
others. Therefore, following the CLIAC recommendation for reevaluation
of these score assignments, some HDL procedures were recategorized from
high to moderate complexity. In response to the comments on the July
26, 1993 test list that announced this group of recategorizations, we
have reevaluated all HDL procedures for consistency in applying the
criteria ``Reagents and Materials Preparation''. Under this criteria, a
score of ``1'' is assigned when the manufacturer provides that analyst
with an automated method of adding quantitative amounts of
precipitating reagent to the sample so that analyst intervention is
minimal, or when the manufacturer provides the analyst with a dedicated
tube containing a single precipitating reagent. As a result of
reevaluating the application of this criteria, the following HDL
procedures have been recategorized from high complexity to moderate
complexity: Abbott TDX, Abbott TDX FLX, Abbott Vision Non Whole Blood
HDL Procedure, and the BioAutoMed ASCA.
Comment: One commenter recommended the recategorization of
``large'' hematology analyzers and microscopy procedures from moderate
to high complexity.
Response: Using the seven criteria established for categorization,
automated hematology analyzers, in general, scored as moderate
complexity. Although the large automated instruments used in hematology
apply multiple principles in their operation, the instruments do not
require extensive analyst intervention or highly specialized knowledge
for operation. Microscopy procedures were also categorized by
complexity using the criteria established for test categorization.
Those procedures which do not require an extensive level of knowledge
or training to perform the evaluation, or do not require an extensive
level of judgment or interpretive skill to recognize or enumerate the
cellular elements under evaluation, generally scored as moderate
complexity.
Comment: One manufacturer requested recategorization of some alpha-
fetoprotein procedures from high complexity to moderate complexity.
Response: Material serum alpha-fetoprotein (AFP) procedures require
extensive training, interpretation and judgment. The analyst must use
patient information related to the weeks of gestation in conjunction
with the procedure value to obtain a reportable result. Amniotic fluid
specimens for AFP may require preanalytic testing to determine the
presence of interfering substances which can lead to result
misinterpretation or they may need manipulation of the sample to
produce a clear supernatant. Extensive interpretive and judgment skills
are also necessary to resolve technical problems, such as improper
specimen collection, or determine the need for repeat testing. All of
these considerations are in addition to those related to the
methodology of the testing procedure. At the present time, all
procedures for maternal serum AFP and amniotic fluid AFP score in the
high complexity category.
Comment: On professional organization voiced support for the high
complexity scores given to any test that involves the interpretation of
cultures and requires multiple steps for the achievement of accurate
results. This organization suggested that other tests now categorized
as moderate complexity should be categorized as high complexity for the
same reasons. The example given was the direct Coombs test, which the
organization indicated would yield a false negative result if the
patient read blood cells were washed insufficiently.
Response: We appreciate the organization's statement of support
concerning the categorization scores of microbiology culture methods.
In regard to the direct antiglobulin test (DAT), or direct Coombs, we
feel that this assay is appropriately categorized as moderate
complexity since the procedural skills are easily acquired, the
reagents are stable and ready to use, and limited knowledge and
judgment is required. The CLIA regulations to do relieve the laboratory
of its responsibility to evaluate the competency of its staff or
provide sufficient training on supervision for the correction of any
technical deficiencies. Training on proper wash techniques to prevent
false negative DAT results should be an integral part of the training
of all analysts performing these procedures. We do not feel that the
degree of [[Page 25946]] decision making, interpretation, and judgment
required to perform a DAT approaches the level required to isolate and
identify organisms from culture.
Comment: Several commenters expressed confusion concerning the
categorization of rapid strep test kits. Some referred to them as high
complexity procedures.
Response: Most of the tests that detect streptococcal antigen
directly from a throat swab are categorized as moderate complexity
tests. They require some knowledge, training and judgment to accurately
perform the procedure. They are not categorized as high complexity
tests because they do not require the level of knowledge, training,
experience and interpretative skill that is required of a high
complexity procedure such as isolation and identification of an
organism from culture.
Comment: Several commenters requested that throat and urine
cultures, and urine susceptibility testing be recategorized from high
to moderate complexity. A few other commenters agreed with high
complexity categorization of microbiology cultures due to the advanced
level of interpretation, judgment, knowledge, and experience required
to obtain an accurate result when performing these procedures.
Response: Isolation, identification, and susceptibility testing of
microorganisms from culture is a complex process regardless of the
source of the culture. It requires significant knowledge, training, and
interpretation for the selection and performance of the individual test
components in this process, which may include staining for microscopic
evaluation, subculturing, and performing the appropriate biochemical
analyses. Taking these factors into consideration when scoring for
complexity, these test systems are appropriately categorized as high
complexity.
Comment: One commenter asked whether the use of general
microbiology culture media, such as sheep blood agar, was categorized.
There has also been some confusion as to whether inoculation of primary
culture media or the determination of a ``No growth'' final culture
result is considered a high complexity test.
Response: Primary inoculation of microbiology culture media (e.g.
blood agar, chocolate agar, MacConkey agar, heart infusion broth) is
not considered a complete test system under the CLIA regulations. The
process of isolation and identification from the primary culture is
considered a total test system. The inoculation of the media becomes
part of the test system when the primary media is observed to determine
whether growth is present after an incubation period. We have
previously stated that if a culture is read even to the point of
providing a result of ``No growth'' it is considered to be an
identification from culture, and, therefore, the laboratory reporting
the result must be certified to perform the entire culture procedure.
In response to the confusion as to whether the determination that there
is either growth or no growth on primary culture plates, including the
final reporting of a ``No growth'' culture result, falls into the
moderate or high complexity category, we have created a new test system
designation, (22167) ``Growth/No Growth of Bacteria on Solid Culture
Media'', which is categorized as moderate complexity. This test system
designation applies to a result determined after examining a culture
from any body site, that was initially inoculated on solid culture agar
or media. It does not apply to cultures inoculated into a broth medium
such as heart infusion broth, thioglycollate medium, or to conventional
broth blood cultures. Final reports for this moderate complexity test
system are limited to ``Growth'', ``Growth--referred for identification
or interpretation'', or ``No growth''. A result of ``No growth'' means
that there are NO bacterial colonies on the media after incubation. The
presence of ``normal flora'', contaminants, or any organism not
considered a pathogen could not be interpreted or reported as ``No
growth''.
Individual biochemical tests that are performed as part of the
total identification process (e.g. oxidase, catalase) are not
categorized as separate tests. Those test systems or kits that usually
contain a group of biochemical or serological tests, and result in the
definitive identification of a microorganism are categorized. Several
selective culture media that do not require transfer from the initial
plate, and result in preliminary identification of a specific
microorganism, have been categorized as moderate complexity tests. The
degree of training and experience, judgment and interpretive skills
required to recognize one specific colony type or reaction on these
selective media is significantly less than what is required for
selecting specific colonies from the growth on primary culture plates,
and performing definitive identification tests on pure cultures of
these organisms.
Comment: One commenter requested that all of the test systems for
dermatophytes that have been categorized and published as moderate
complexity should be recategorized as high complexity due to the
advanced level of interpretation, judgment, knowledge, and experience
required to obtain an accurate result.
Response: The test systems for dermatophytes that have been
categorized as moderate complexity are tests performed on selective
media that detect the presence or absence of dermatophytes, but do not
identify these fungi. These test systems require significantly less
knowledge, experience, interpretation, and judgment than high
complexity cultures for isolation and complete identification of fungi,
in which organisms must be transferred and identification procedures
performed. Based on the information we have received to date, we
believe that the test systems for dermatophytes using selective media
are appropriately categorized as moderate complexity.
Comment: Several commenters requested that the following analytes
and test systems be recategorized from moderate to high complexity:
N. gonorrhoeae (from urogenital or rectal only)
Test system--All presumpt. ID using select, media, oxidase, and
gram stain
Streptococcus, group A (from throat only)
Test system--All presumpt. ID w/selective media, hemolysis, and
bacitracin
Response: These two tests for presumptive identification of a
single microorganism on selective media from culture of a specific body
site were placed in the moderate complexity category because the
knowledge, training, interpretation and judgment required is
significantly less than that needed to distinguish multiple organisms
and determine the presence of pathogens, normal flora, or contamination
in a culture initially inoculated on general nonselective culture
media. For these reasons, we disagree with these commenters, and these
tests will remain categorized as moderately complex.
Comment: One commenter requested that Gram stain procedures
performed on endocervical specimens be recatogorized from moderate to
high complexity.
Response: Gram stains from urethral and endocervical smears are
categorized as moderate complexity procedures, while Gram stains from
other sources are categorized as high complexity procedures as
determined by the scoring criteria established for test categorization.
Smears from urethral and endocervical sources do not tend to
[[Page 25947]] contain the variety of microorganisms or cell types that
can be seen on smears taken from other sources. Therefore, the
knowledge, training and experience, interpretation and judgment
required to interpret a Gram stained smear from urethral or
endocervical sources is not as extensive as that required to interpret
gram stain smears from other sources. Although we agree that there is a
difference in the interpretation and judgment required for Gram stained
smears from urethral versus endocervical sources, we do not believe
that difference is sufficient to place the Gram stain evaluations
performed on endocervical smears into high complexity. This issue was
presented to, and discussed by, CLIAC. The CLIAC felt that CDC's
assessment of the level of difficulty for performing the evaluations
was appropriate, thus the Gram stain of endocervical smears will remain
in the moderate complexity category.
Comment: One commenter requested that the MAST CLA-1 Luminometer
System be recategorized from high to moderate complexity. The commenter
noted that this is a different request from earlier correspondence
requesting that the MAST Allergy Densitometer System be recategorized
from high to moderate complexity.
Response: We would like to emphasize that we assess the complexity
of every analyte on each individual instrument and do not categorize
instruments by complexity without analytes. Additionally, the entire
testing process of preanalytic, analytic, and postanalytic steps,
including the process for determination of results, are evaluated for
categorization. Thus the instrument used to read the final results is
not graded independently of the total testing process. The analytes for
which the MAST CLA Allergy System has been categorized as a high
complexity test system are ``allergen specific IgE'' and
``immunoglobulins IgE''.
As in our earlier response regarding the MAST CLA Allergy System,
we maintain that high complexity is the appropriate complexity rating
for the MAST CLA Allergy System. While it is true that there are two
different means to measure test results for this procedure, i.e., by
densitometer or by using the MAST Chemiluminescent Analyzer (CLA-1),
these measuring devices do not significantly change the complexity of
the entire testing process. Substantial training and experience are
required to perform the complete procedure. The steps in the procedure
are manually executed and are performed in the same way except for
result reading and data reduction. Regardless of the reading system
used, the analyst must prepare multiple reagents prior to testing, some
of which require special handling; the process requires manual addition
of specimen to the chamber using a syringe, followed by timed
incubation, multiple wash steps, addition of reagents, a second timed
incubation and more wash steps. It is only after these second wash
steps are completed that the CLA-1 Chemiluminescent Analyzer automates
the photodevelopment, result reading and data reduction, while the
Densitometer system requires manual photodevelopment, followed by
result reading and data reduction on the instrument.
We have reviewed the MAST CLA Allergy System taking into account
both methods of final result determination and have concluded that due
to the knowledge, training and skills necessary to perform the IgE
assays properly, this test system belongs in the high complexity
category. However, for purposes of clarification, we have listed the
system in this Notice in such way that the method of result
determination is clearly specified, and it is now listed twice, as
follows: (40176) MAST CLA Allergy System (densitometer) and (40177)
MAST CLA-1 Chemiluminescent Allergy System. Both are categorized as
high complexity.
Comment: One commenter requested that the Scandipharm CF INDICATOR
SWEAT TEST SYSTEM (CFIS) be given the same status as the physician-
performed microscopy procedures so that access to cystic fibrosis
screening would not be restricted.
Response: The Scandipharm CF INDICATOR SWEAT TEST SYSTEM (CFIS)
does not meet the criteria for physician-performed microscopy
procedures (PPM). The PPM examinations include only specific
microscopic procedures performed on specimens that are derived from
patients as part of the physical examination. We have received numerous
comments suggesting that another level of complexity be established
that is intermediate between waived and moderate complexity. HHS is
taking these suggestions under advisement.
Additions to Waived Category
The Ames Glucometer ENCORE QA Blood Glucose Meter (04423) and the
Ames Glucometer QA Blood Glucose Meter (04422) have been deleted from
the list of moderate complexity tests and have been added to the list
of waived tests. Section Sec. 493.15(c) of the CLIA regulations lists
``blood glucose by glucose monitoring devices cleared by the FDA
specifically for home use'' as waived tests. The Ames Glucometers are
glucose monitoring devices that were recently cleared by the FDA for
home use; therefore, they are now listed as waived tests.
Please note that in this list of additions to the CLIA test
categorization list, we have included the test systems (58311)
Separation Technology STI HemataStat II and (58309) Separation
Technology STI HemataStat Model C70 under the analyte (9581) Spun
Microhematocrit as waived procedures. On previous lists of waived
procedures, we did not list individual test systems capable of
obtaining results for spun hematocrit, but rather listed the all-
inclusive test system designation (04420) ``All Spun Microhematocrit
Procedures''. The two Separation Technology test systems have been
listed in response to requests from the public to clarify that these
test systems are indeed spun microhematocrit procedures. The all-
inclusive test system designation (04420) will continue to be included
on the waived list to indicate that, at the present time, all spun
microhematocrit test systems are waived procedures. We do encourage the
public to contact us if there are questions about whether other
specific test systems meet this definition. In the future, we will
include all test systems by manufacturer's name on the waived list.
Additions
In this publication, we are announcing the categorization of two
laboratory procedures that are normally performed in dental offices.
The dental procedures for (4965) Proteolytic enzymes are listed in the
speciality of General Chemistry, and for (1317) Dental plaque, in
bacteriology.
Corrections
The following corrections to the list of test systems, assays and
examinations published previously in the Federal Register are based on
supplemental information provided by the commenters during the comment
period or as a result of corrections of data entry errors. The CDC
should be notified of any changes in manufacture or test system names
so that these changes can be included in the next published test list.
Scandipharm CF Indicator (58240):
The Scandipharm CF Indicator (58240) (Cystic Fibrosis Sweat Test)
has been deleted from the high complexity category and placed in the
moderate complexity category based upon new [[Page 25948]] information
supplied by the manufacturer regarding the sample collection. Previous
information had indicated that the amount of analyst involvement in the
collection of the sample was more extensive than that indicated in the
new information. Upon evaluation of this information supplied by the
manufacturer, it was determined that the training and experience and
interpretation and judgment required by the analyst to successfully
perform the sample collection is not as extensive as originally
indicated. As a result of the adjustment of scores for relevant
criteria, the Scandipharm CF Indicator now registers a total score that
places it in the moderate complexity category.
International Technidyne Corporation:
As noted in the preamble to the compiled test list, the analyte
heparin was removed from the International Technidyne Corporation
systems because the relevant analytes were either (2539) heparin dose
response (HDR) or (2538) heparin/protamine titration (HPT). These
systems were inadvertently omitted in the compiled test list for the
analytes HDR or HPT. This error has been corrected in the database and
the systems are listed in this Notice under the appropriate analytes.
(2502) HCG, Serum, Quantitative:
The analyte, HCG, Serum, Quantitative, has been clarified as (2502)
HCG, Beta, Serum, Quantitative.
(4945) Protamine Rate Titration (PRT)
The analyte (4945) Protamine Rate Titration for the International
Technidyne Hemochron test systems has been corrected to (4945)
Protamine Response Test (PRT).
MicroProbe Affirm VP Identification Kit (40135) for the detection and
identification of (2212) Gardnerella vaginalis:
Identification of G. vaginalis using the MicroProbe Affirm VP
Identification Kit is categorized as a moderate complexity test, and is
correctly listed as such on page 39879 of the July 26, 1993 Federal
Register notice, in the List of Previously Unpublished Categorizations.
The erroneous listing of this analyte and test system as high
complexity in the compiled test list of categorizations has been
corrected in this Federal Register Notice.
Bio-Scan Bio-Gen:
The manufacturer's name was inadvertently omitted from several
entries for Bio-Gen test systems, listed under (9641) Urine Dipstick or
Tablet Analytes, Nonautomated. These entries have been corrected to
read Bio-Scan Bio-Gen in this notice.
Access Medical Systems ImmunoClone HCG Test (04377):
An entry under HCG, Serum, Qualitative, was incorrectly listed as
Access Medical Systems ImmunoClone (direct Ag/visual) (04311) and has
been revised to read Access Medical Systems ImmunoClone HCG Test
(04377).
bioMerieux Vitek Vidas (07434):
The test system bioMerieux Vitek Vidas (07434) for the analyte
(6111) Thyroxine, Free (FT4) has been revised to Vitek Systems Vidas
(67038) for consistency in the listing of test systems, assays, and
examinations.
Incorrect Test System Codes
Incorrect test system codes were inadvertently assigned to several
systems on the previous test list and have been corrected as follows:
Gen-Probe Legionella Rapid Diag. Systems (including culture) was
incorrectly assigned the test system code (22126). The correct code is
(22160).
Gen-Probe M. Pneumoniae Rapid Diag. Systems (including culture) was
incorrectly assigned the test system code (22127). The correct code is
(22161).
Gull Laboratories RSV-Mab Test (direct antigen) was incorrectly
assigned the test system code (22128). The correct code is (22162).
Seradyn Colorvue--Giardia (direct Ag/visual) was incorrectly
assigned the test system code (58100). The correct code is (58296).
Seradyn Colorvue--Cryptosporidium (direct Ag/visual) was
incorrectly assigned the test system code (58101). The correct code is
(58297).
Deletions
(4023) Myoglobin:
The analyte myoglobin was listed in both the General Chemistry and
Immunology speciality areas. It has been deleted from the Immunology
speciality area.
(0444) Anti-Reticulin Antibodies:
Anti-Reticulin Antibodies on the Scimedx Auto Screen Test System
(58016) has been deleted because it has not been cleared by FDA for use
in the clinical laboratory.
(5503) Respiratory viruses (Influenza A&B, parainfluenza):
The analyte Respiratory viruses (Influenza A&B, parainfluenza) has
been deleted and replaced with the following analytes: (0410)
Adenovirus, (2828) Influenza A, (2829) Influenza B, (4959)
Parainfluenza 1, (4960) Parainfluenza 2, (4961) Parainfluenza 3, and
(5503) Respiratory syncytial virus.
(0456) Antithrombin III (ATIII):
Instrumentation Laboratory IL ACL 100 (28073) has been deleted from
the analyte (0456) Antithrombin III (ATIII) because this analyte is not
available on this system.
(0703) Beta-2 microglobulin:
Du Pont Medical Products aca II (13172) has been deleted from the
analyte beta-2 microglobulin because this analyte is not available on
this system.
(4908) Platelet Count:
The test systems Abbott Cell-Dyn 400 (04230), Abbott Cell-Dyn 500
(04231), and Abbott Cell-Dyn 700 (04233) have been deleted from the
analyte platelet count because these instruments do not analyze this
analyte.
Analyte Nomenclature and Use
We will use the term ``direct bilirubin'' to refer to the analyte
``conjugated bilirubin''.
Due to the different nomenclature systems associated with many flow
cytometer analytes, we will list each analyte by the terminology
furnished by the manufacturer.
Thyroid Peroxidase Autoantibodies (TPO) and Anti-Thyroid Microsomal
Antibodies (AMA) refer to the same analyte. To avoid confusion, we will
list the analyte nomenclature used by the manufacturer in the package
insert for the test system being categorized.
For purposes of clarification, the analyte (1033) for Cortisol,
Urine has been modified to read Cortisol, Urine (direct procedure), and
a new analyte (1095) Cortisol, Urine (extraction procedure) has been
established.
Speciality/Subspeciality Changes
In previous publications of the Test Categorization List, analyte/
test systems were assigned to speciality/subspeciality categories based
upon the most recognized area in the clinical laboratory where these
procedures are generally performed. In an effort to coordinate
regulatory responsibilities between the Health Care Financing
Administration (HCFA) and the CDC, we have redefined the speciality/
subspeciality categories for some analytes to conform to HCFA's common
procedure coding system for Medicare payment. Consequently, in this
publication, you will note that the analytes (0476) Acetylcholine/
choline, [[Page 25949]] (0426) Aminoglycosides, (0705) Blood Lead,
(1012) Carboxyhemoglobin, (2541) Histamine, and (3712) Lithium have
been moved to Toxicology; the analytes (0424) Alpha Fetoprotein--tumor
marker, (1051) C1-Esterase Inhibitor (C1INH), and (4927) Platelet
Antibody--detection have been moved to General Immunology; the analytes
(1049) Cancer Antigen 125 (CA125), (1013) Carcinoembryonic Antigen
(CEA), (1015) Ceruloplasmin, (2511) Haptoglobin, (3717) Lysozyme,
(4911) Prealbumin, (4919) Prostatic Specific Antigen (PSA), (4920)
Protein Fractions, (6114) Transferrin, and (6129) Trypsin have been
moved to General Chemistry; the analyte (4021) Malarial Parasite has
been moved to Parasitology. Also, a number of analytes that were
previously listed under the speciality of General Chemistry or the
subspeciality of Toxicology are now listed under the subspeciality of
Endocrinology. These analytes, with their respective codes, are:
(0106) 17 Ketosteroid
(0102) 17 OH Progesterone
(0103) 17 OH Progesterone, Neonatal
(0101) 5-Hydroxyindolacetic Acid (5-HIAA)
(0472) Adenosine Monophosphate, Cyclic (cAMP)
(0458) Adrenocorticotropic Hormone (ACTH)
(0459) Aldosterone
(0466) Androstanediol Glucuronide (3 alpha-diol G)
(0460) Androstenedione
(0479) Angiotensin I
(1040) Calcitonin
(1056) Catecholamines, Plasma
(1055) Catecholamines, Urine
(1032) Cortisol
(1033) Cortisol, Urine (direct procedure)
(1095) Cortisol, Urine (extraction procedure)
(1043) Cyclic AMP
(1309) Dehydroepiandrosterone (DHEA)
(1310) Dehydroepiandrosterone Sulfate (DHEA-SO4
(1611) Erythropoietin
(1605) Estradiol
(1606) Estriol-Total
(1607) Estriol-unconjugated
(1908) Follicle Stimulating Hormone (FSH)
(2205) Gastrin
(2206) Glucagon
(2502) HCG, Beta, Serum, Quantitative
(2501) HCG, Serum, Qualitative
(2555) HCG, Total, Serum, Quantitative
(2503) HCG, Urine, Qualitative (non-waived procedures)
(2534) HCG, Urine, Quantitative
(2543) HCG, Whole Blood, Qualitative
(2545) Homovanillic Acid (HVA)
(2547) Human Growth Hormone
(2533) Human Placental Lactogen (hPL)
(2812) Insulin
(2818) Insulin-like Growth Factor-1 (IGF-1)
(3713) Luteinizing Hormone (LH)
(4025) Metanephrines, Urine
(4934) Parathyroid Hormone--C-Terminal
(4924) Parathyroid Hormone--Intact
(4925) Parathyroid Hormone--Mid-molecule (PTH-M)
(4914) Progesterone
(4915) Prolactin
(5515) Renin
(5820) Serotonin
(5819) Sex Hormone Binding Globulin
(6102) Testosterone
(6122) Testosterone, Free
(6110) Thyroid Binding Globulin (TBG)
(6106) Thyroid Stimulating Hormone (TSH)
(6107) Thyroid Stimulating Hormone (TSH) (Neonatal)
(6108) Thyroid Stimulating Hormone--high sens. (TSH-HS)
(6109) Thyroxine (T4)
(6123) Thyroxine (T4), Neonatal
(6110) Thyroxine Binding Globulin (TBG)
(6111) Thyroxine, Free (FT4)
(6119) Triiodothyronine (T3)
(6120) Triiodothyronine Uptake (T3U) (TU)
(6121) Triiodothyronine, Free (FT3)
(6710) Vanillylmandelic Acid (VMA)
Dated: May 2, 1995.
Philip R. Lee,
Assistant Secretary for Health.
List of Previously Unpublished Categorizations
The test categorization scoring scheme was based on an assessment
of the complexity of the operation of the test procedure and not on an
evaluation of data documenting the procedure's performance over time.
Therefore, the categorization of a test system, assay or examination as
moderate or high complexity should not be interpreted as an indication
of the acceptability or unacceptability of the accuracy, precision or
overall performance of the procedure.
COMPLEXITY: MODERATE
SPECIALITY/SUBSPECIALITY: Bacteriology
ANALYTE: Aerobic &/or Anaerobic Organisms-unlimited sources (0412)
TEST SYSTEM, ASSAY OR EXAMINATION:
Difco ESP Blood Culturing System (13275)
Growth/No Growth of Bacteria on Solid Culture Media (22167)
Organon Teknika Bact/Alert 120 (46148)
ANALYTE: Aerobic Organisms from urine specimens only (0468)
TEST SYSTEM, ASSAY OR EXAMINATION:
Difco EZ Streak Urine Culture Device (colony court only) (13311)
Savyon Diagnostic DIASLIDE (colony count only) (58290)
Traditional Blood Agar Streak Plate (colony count only) (61131)
Vitek Systems Bac-T-Screen 2000 (bacteriuria) (67039)
Vitek Systems Bac-T-Screen 402A (bacteriuria) (67049)
Vitek Systems Bac-T-Screen 500 (bacteriuria) (67050)
ANALYTE: Chlamydia (1016)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott TestPack Chlamydia (direct antigen/visual) (04518)
Wampole Clearview Chlamydia (direct antigen/visual) (70140)
ANALYTE: Clostridium difficile (1022)
TEST SYSTEM, ASSAY OR EXAMINATION:
Meridian Diagnostics ImmunoCard C. difficile (dir.Ag/visual)
(40165)
ANALYTE: Gardnerella vaginalis (2212)
TEST SYSTEM, ASSAY OR EXAMINATION:
MicroProbe Affirm VP Microbial Identification Test Kit (40135)
MicroProbe Affirm VPIII Microbial Identification Test (40163)
ANALYTE: Helicobacter pylori (2512)
TEST SYSTEM, ASSAY OR EXAMINATION:
Serim PyloriTek Test Kit (58338)
ANALYTE: Streptococcus, group A (5810)
TEST SYSTEM, ASSAY OR EXAMINATION:
Becton Dickinson Precise STREP A (direct antigen/visual) (07426)
Syntron QuikPac Strep A (EIA) Test (direct antigen/visual)
(58291)
Wampole Clearview Strep A (direct antigen/visual) (70141)
ANALYTE: Streptococcus, group A (from throat only) (5828)
TEST SYSTEM, ASSAY OR EXAMINATION:
Medix Biotech BESTest Strep A (40193)
Quidel QuickVue One-Step Strep A Test (52024)
ANALYTE: Streptococcus, group B (5811)
TEST SYSTEM, ASSAY OR EXAMINATION:
BioStar Strep B OIA (direct antigen/visual) (07540)
ANALYTE: Vibrio cholerae (6716)
TEST SYSTEM, ASSAY OR EXAMINATION:
New Horizons CholeraScreen (43084)
SPECIALITY/SUBSPECIALITY: Endocrinology
ANALYTE: Cortisol (1032)
TEST SYSTEM, ASSAY OR EXAMINATION:
Boehringer Mannheim ES 300 AL (07524)
Boehringer Mannheim Hitachi 914 (07546)
Ciba Corning ACS 180 (10046)
Cirrus Diagnostics Immulite (10159)
Sanofi Pasteur Access Immunoassay System (58257)
Schiapparelli Biosystems ACE Clinical Chemistry System
(58288) [[Page 25950]]
Vitek Systems Vidas (67038)
ANALYTE: Cortisol, Urine (direct procedure) (1033)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott TDX (04071)
Sanofi Pasteur Access Immunoassay System (58257)
ANALYTE: Dehydroepiandrosterone (DHEA) (1309)
TEST SYSTEM, ASSAY OR EXAMINATION:
Serono Baker SR 1 (58090)
ANALYTE: Dehydroepiandrosterone Sulfate (DHEA-SO4) (1310)
TEST SYSTEM, ASSAY OR EXAMINATION:
Cirrus Diagnostics Immulite (10159)
ANALYTE: Estradiol (1605)
TEST SYSTEM, ASSAY OR EXAMINATION:
Baxter Stratus II (07051)
Baxter Stratus IIntellect (07376)
Boehringer Mannheim ES 300 AL (07524)
Ciba Corning ACS 180 (10046)
Cirrus Diagnostics Immulite (10159)
PB Diagnostics Systems OPUS (49001)
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS PLUS (49098)
TOSOH A1A-1200 (61040)
TOSOH A1A-600 (61039)
Vitek Systems Vidas (67038)
Wallac Oy AutoDELFIA (70167)
ANALYTE: Estriol-unconjugated (1607)
TEST SYSTEM, ASSAY OR EXAMINATION:
Wallac Oy AutoDELFIA (70167)
ANALYTE: Follicle Stimulating Hormone (FSH) (1908)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott AxSYM (04532)
Boehringer Mannheim ES 300 AL (07524)
Du Pont ACA III with aca plus Immunoassay System (13253)
Du Pont ACA IV with aca plus Immunoassay System (13254)
Du Pont ACA SX with aca plus Immunoassay System (13313)
Du Pont ACA Star with aca plus Immunoassay System (13358)
Du Pont ACA V with aca plus Immunoassay System (13255)
Organon Teknika AuraFlex (46152)
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS PLUS (49098)
Roche Cobas Core (55119)
Sanofi Pasteur Access Immunoassay System (58257)
Syva Vista Immunoassay System (58221)
Vitek Systems Vidas (67038)
Wallac Oy AutoDELFIA (70167)
ANALYTE: HCG, Beta, Serum, Quantitative (2502)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott AxSYM (04532)
Boehringer Mannheim ES 300 AL (07524)
Du Pont ACA Star with aca plus Immunoassay System (13358)
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS PLUS (49098)
Sanofi Pasteur Access Immunoassay System (58257)
Syva Vista Immunoassay System (58221)
Vitek Systems Vidas (67038)
Wallac Oy AutoDELFIA (70167)
ANALYTE: HCG, Serum, Qualitative (2501)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott TestPack PLUS hCG COMBO (04375)
Access Medical Systems ImmunoCLONE hCG Test (04377)
Applied Biotech SureStep Combo hCG (04528)
Disease Detection International Pro-Step PT hCG (13271)
Disease Detection International Pro-Step hCG (13270)
King's Bay Prelude hCG Combo Kit (34062)
Mainline Technology MAINLINE Confirms hCG (40190)
Princeton BioMeditech BioSign hCG One Step Pregnancy Test
(49080)
Quidel QuickVue One-Step hCG Combo Test (52022)
SA Scientific SAS Serum/Urine hCG (58283)
Stanbio QuPid Plus hCG Pregnancy Test (58326)
Syntron Bioresearch QuikPac II hCG Combo Kit (58353)
TECH-CO Visual HCG Pregnancy Test (61099)
True Medix Beta Spec hCG (61139)
Unipath Clearview HCG DUO (64031)
ANALYTE: HCG, Total, Serum, Quantitative (2555)
TEST SYSTEM, ASSAY OR EXAMINATION:
Ciba Corning ACS 180 (10046)
PB Diagnostics Systems OPUS (49001)
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS PLUS (49098)
ANALYTE: HCG, Urine, Qualitative (non-waived procedures) (2503)
TEST SYSTEM, ASSAY OR EXAMINATION:
Applied Biotech Pregslide HCG Test (04498)
Diagnostic Specialties Pregna-Cert (13276)
J & S Medical Accutex B-HCG Latex Test (31011)
SA Scientific SAS Direct Monoclonal hCG (58319)
SA Scientific SAS Monoclonal HCG-Slide (58281)
ANALYTE: Human Growth Hormone (GH) (2547)
TEST SYSTEM, ASSAY OR EXAMINATION:
Wallac Oy AutoDELFIA (70167)
ANALYTE: Insulin (2812)
TEST SYSTEM, ASSAY OR EXAMINATION:
Boehringer Mannheim ES 300 AL (07524)
ANALYTE: Luteinizing Hormone (LH) (3713)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott AxSYM (04532)
Boehringer Mannheim ES 300 AL (07524)
Du Pont ACA III with aca plus Immunoassay System (13253)
Du Pont ACA IV with aca plus Immunoassay System (13254)
Du Pont ACA Star with aca plus Immunoassay System (13358)
Du Pont ACA V with aca plus Immunoassay System (13255)
Organon Teknika AuraFlex (46152)
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS PLUS (49098)
Roche Cobas Core (55119)
Sanofi Pasteur Access Immunoassay System (58257)
Syva Vista Immunoassay System (58221)
Vitek Systems Vidas (67038)
Wallac Oy AutoDELFIA (70167)
ANALYTE: Parathyroid Hormone--Intact (4924)
TEST SYSTEM, ASSAY OR EXAMINATION:
Cirrus Diagnostics Immulite (10159)
ANALYTE: Progesterone (4914)
TEST SYSTEM, ASSAY OR EXAMINATION:
Baxter Stratus II (07051)
Baxter Stratus IIntellect (07376)
Boehringer Mannheim ES 300 AL (07524)
Ciba Corning ACS 180 (10046)
Cirrus Diagnostics Immulite (10159)
TOSOH A1A-1200 (61040)
TOSOH A1A-600 (61039)
Wallac Oy AutoDELFIA (70167)
ANALYTE: Prolactin (4915)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott AxSYM (04532)
Boehringer Mannheim ES 300 AL (07524)
Cirrus Diagnostics Immulite (10159)
Du Pont ACA III with aca plus Immunoassay System (13253)
Du Pont ACA IV with aca plus Immunoassay System (13254)
Du Pont ACA SX with aca Immunoassay System (13313)
Du Pont ACA Star with aca plus Immunoassay System (13358)
Du Pont ACA V with aca plus Immunoassay System (13255)
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS PLUS (49098)
Roche Cobas Core (55119)
Sanofi Pasteur Access Immunoassay System (58257)
Syva Vista Immunoassay System (58221)
Vitek Systems Vidas (67038)
Wallac Oy AutoDELFIA (70167)
ANALYTE: Sex Hormone Binding Globulin (5819)
TEST SYSTEM, ASSAY OR EXAMINATION:
Cirrus Diagnostics Immulite (10159)
ANALYTE: Testosterone (6102)
TEST SYSTEM, ASSAY OR EXAMINATION:
Ciba Corning ACS 180 (10046)
ANALYTE: Thyroid Stimulating Hormone (TSH) (6106)
TEST SYSTEM, ASSAY OR EXAMINATION: [[Page 25951]]
Bio-Rad RADIAS System (07493)
Cirrus Diagnostics Immulite (10159)
Du Pont ACA Star with aca plus Immunoassay System (13358)
Organon Teknika AuraFlex (46152)
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS PLUS (49098)
Roche Cobas Core (55119)
Vitek Systems Vidas (67038)
Wallac OY AutoDELFIA (70167)
ANALYTE: Thyroid Stimulating Hormone (TSH) (Neonatal) (6107)
TEST SYSTEM, ASSAY OR EXAMINATION:
Bio-Rad RADIAS System (07493)
ANALYTE: Thyroid Stimulating Hormone--high sens. (TSH-HS) (6108)
TEST SYSTEM, ASSAY OR EXAMINATION:
Bio-Rad RADIAS System (07493)
Boehringer Mannheim ES 300 AL (07524)
Sanofi Pasteur Access Immunoassay System (58257)
Wallac Oy AutoDELFIA (70167)
ANALYTE: Thyroxine (T4) (6109)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott AxSYM (04532)
Beckman Synchron CX 5 CE (07491)
Becton Dickinson IQ Immunochemical System (07429)
Boehringer Mannheim ES 300 AL (07524)
Boehringer Mannheim Hitachi 911 (07377)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
Olympus AU 5121 (46087)
Olympus AU 5200 (46143)
Organon Teknika AuraFlex (46152)
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS PLUS (49098)
Roche Cobas Core (55119)
Sanofi Pasteur Access Immunoassay System (58257)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Technicon OPERA Clinical Chemistry System (61161)
Vitek Systems Vidas (67038)
Wallac Oy AutoDELFIA (70167)
ANALYTE: Thyroxine Binding Globulin (TBG) (6110)
TEST SYSTEM, ASSAY OR EXAMINATION:
Boehringer Mannheim ES 300 AL (07524)
Technicon Immuno 1 System (61042)
ANALYTE: Thyroxine Uptake (T4U) (TU) (6139)
TEST SYSTEM, ASSAY OR EXAMINATION:
Du Pont Dimension XL (13355)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Syva Vista Immunoassay System (58221)
Vitek Systems Vidas (67038)
ANALYTE: Thyroxine, Free (FT4) (6111)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott AxSYM (04532)
Bio-Rad RADIAS System (07493)
Boehringer Mannheim ES 300 AL (07524)
Cirrus Diagnostics Immulite (10159)
Organon Teknika AuraFlex (46152)
PB Diagnostics Systems OPUS (49001)
Roche Cobas Core (55119)
Sanofi Pasteur Access Immunoassay System (58257)
Technicon Immuno 1 System (61042)
Vitek Systems Vidas (67038)
Wallac Oy AutoDELFIA (60167)
ANALYTE: Triiodothyronine (T3) (6119)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott AxSYM (04532)
Boehringer Mannheim ES 300 AL (07524)
Organon Teknika AuraFlex (46152)
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS PLUS (49098)
Roche Cobas Core (55119)
Sanofi Pasteur Access Immunoassay System (58257)
TOSOH A1A-120DX (61154)
Vitek Systems Vidas (67038)
Wallac Oy AutoDELFIA (70167)
ANALYTE: Triiodothyronine Uptake (T3U) (TU) (6120)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott TDX FLx (04072)
Beckman Synchron CX 5 CE (07491)
Becton Dickinson IQ Immunochemical System (07429)
Boehringer Mannheim ES 300 AL (07524)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
Olympus AU 5121 (46087)
Olympus AU 5200 (46143)
Organon Teknika AuraFlex (46152)
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS PLUS (49098)
Sanofi Pasteur Access Immunoassay System (58257)
SPECIALITY/SUBSPECIALITY: General Chemistry
ANALYTE: Acid Phosphatase (0407)
TEST SYSTEM, ASSAY OR EXAMINATION:
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Kodak Ektachem 500 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
ANALYTE: Alanine Aminotransferase (ALT) (SGPT) (0404)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Albumin (0414)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Beckman Synchron CX 5 CE (07491)
Behring Nephelometer II (07563)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34504)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Albumin, Urinary (0516)
TEST SYSTEM, ASSAY OR EXAMINATION:
Du Pont ACA II (13172)
Du Pont ACA III (13173)
Du Pont ACA IV (13083)
Du Pont ACA Star (13357)
Du Pont ACA V (13084)
ANALYTE: Aldolase (0415)
TEST SYSTEM, ASSAY OR EXAMINATION:
Boehringer Mannheim Hitachi 914 (07546)
ANALYTE: Alkaline Phosphatase (ALP) (0416)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056) [[Page 25952]]
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Synermed IR 500 (58322)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Alpha-Hydroxybutyrate Dehydrogenase (HBDH) (0419)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 5 CE (07491)
Du Pont ACA Star (13357)
ANALYTE: Ammonia, Plasma/Serum (0427)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Abbott VP (04082)
Beckman Synchron CX 4 CE (07174)
Beckman Synchron CX 5 CE (07491)
Beckman Synchron CX 7 (07073)
Boehringer Mannheim Hitachi 911 (07377)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
ANALYTE: Amylase (0429)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Amylase, pancreatic isoenzymes (p-Amylase) (0500)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 4 (07071)
Beckman Synchron CX 5 (07072)
Boehringer Mannheim Hitachi 704 (07161)
Boehringer Mannheim Hitachi 705 (07162)
Boehringer Mannheim Hitachi 717 (07163)
Boehringer Mannheim Hitachi 747 (07166)
Boehringer Mannheim Hitachi 911 (07377)
ANALYTE: Apolipoprotein A1 (0462)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelometer II (07563)
Instrumentation Laboratory IL Monarch 1000 (28082)
Instrumentation Laboratory IL Monarch 2000 (28231)
Instrumentation Laboratory IL Monarch Plus (28083)
Olympus AU 5041 (46145)
ANALYTE: Apolipoprotein B (0457)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelometer II (07563)
Olympus AU 5041 (46145)
ANALYTE: Aspartate Aminotransferase (AST) (SGOT) (0405)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abaxis EPOC 2000 (04547)
Abbott Spectrum CCX (04515)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
Olympus AU 5131 (46088)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Synermed IR 500 (58322)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Bilirubin, Direct (0704)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCS (04515)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
LSI ASCA Chemistry System (37069)
Olmpus AU 5041 (46145)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Bilirubin, Neonatal (0705)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Du Pont ACA Star (13357)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem DT II (34057)
ANALYTE: Bilirubin, Total (0706)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abaxis EPOC 2000 (04547)
Abbott Spectrum CCX (04515)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Techicon OPERA Clinical Chemistry System (61161)
ANALYTE: Blood Gases with pH (0708)
TEST SYSTEM, ASSAY OR EXAMINATION:
AVL Compact 1 (04552)
AVL Compact 2 (04555)
AVL OPTI 1 (04572)
Ciba Corning 248 (10260)
Ciba Corning 840 (10250)
Ciba Corning 845 (10296)
Ciba Corning 850 (10251)
Ciba Corning 855 (10297)
Ciba Corning 860 (10269)
Ciba Corning 865 (10298)
Diametrics Medical DMI Blood Gas Analyzer (13274)
Diametrics Medical IRMA Blood Analysis System (13362)
I-STAT i-STAT 200 System (28344)
I-STAT i-STAT Portable Clinical Analyzer (28186)
Instrumentation Laboratory Blood Gas 1610 (28335)
Instrumentation Laboratory Blood Gas 1620 (28336)
Instrumentation Laboratory Blood Gas 1630 (28337)
Instumentation Laboratory Blood Gas 1640 (28338)
Instrumentation Laboratory Blood Gas 1650
(28339) [[Page 25953]]
Instrumentation Laboratory IL 1430 BGElectrolyte (28343)
Nova Stat profile 7 (43035)
Nova Stat Profile 9 (43086)
Nova Stat Profile Plus 10 (43063)
Nova Stat Profile Ultra 11P Analyzer (43101)
PPG Industries StatPal II Blood Gas Analysis System (49092)
Radiometer ABL 5 (55136)
Radiometer ABL 620 (55137)
ANALYTE: Blood pH (no blood gases) (07221)
TEST SYSTEM, ASSAY OR EXAMINATION:
AVL 9110 pH Analyzer (04523)
AVL 988-4 (04556)
Ionetics Model 400/450 Electrolyte Analyzer (28324)
Medica EasyLyte Calcium Analyzer (40197)
ANALYTE: Calcium, Ionized (1004)
TEST SYSTEM, ASSAY OR EXAMINATION:
AVL 988-4 (04556)
Ciba Corning 850 (10251)
Ciba Corning 855 (10297)
Ciba Corning 860 (10269)
Ciba Corning 865 (10298)
Diametrics Medical IRMA Blood Analysis System (13362)
I-STAT i-STAT 200 System (28344)
I-STAT i-STAT Portable Clinical Analyzer (28186)
Instrumentation Laboratory Blood Gas 1640 (28338)
Ionetics Model 400/450 Electrolyte Analyzer (28324)
Medica EasyLyte Calcium Analyzer (40197)
Nova Stat Profile 9 (43086)
Nova Stat Profile Ultra 11P Analyzer (43101)
Radiometer ABL 620 (55137)
Radiometer EML 100 (55134)
ANALYTE: Calcium, Total (1005)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Beckman Synchron AS-X (07069)
Beckman Synchron CX 3 Delta (07548)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Nova 10 (with CRT) (43061)
Olympus AU 5041 (46145)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Synermed IR 500 (58322)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Carbon Dioxide, Total (CO<INF>2) (1003)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Beckman Synchron CX 3 Delta (07548)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Nova 16 (43103)
Olympus AU 5041 (46145)
Olympus AU 5121 (46087)
Olympus AU 5200 (46143)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Carcinoembryonic Antigen (CEA) (1013)
TEST SYSTEM, ASSAY OR EXAMINATION:
Boehringer Mannheim ES 300 (07160)
TOSOH A1A-600 (61039)
ANALYTE: Cerebrospinal Fluid (CSF) Protein (1014)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 4 (07071)
Beckman Synchron CX 4 CE (07174)
Beckman Synchron CX 5 (07072)
Beckman Synchron CX 7 (07073)
Boehringer Mannheim Hitachi 704 (07161)
Boehringer Mannheim Hitachi 717 (07163)
Boehringer Mannheim Hitachi 747 (07166)
Boehringer Mannheim Hitachi 911 (07377)
Du Pont ACA Star (13357)
Du Pont Dimension (13086)
Du Pont Dimension AR (13087)
Du Pont Dimension ES (13215)
Du Pont Dimension XL (13355)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
ANALYTE: Ceruloplasmin (1015)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelometer II (07563)
ANALYTE: Chloride (1018)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 3 Delta (07548)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Ciba Corning 850 (10251)
Ciba Corning 855 (10297)
Ciba Corning 860 (10269)
Ciba Corning 865 (10298)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
I-STAT i-STAT 200 System (28344)
Instrumentation Laboratory Blood Gas 1650 (28339)
Instrumentation Laboratory IL 1430 BGElectrolyte (28343)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Instrumentation Laboratory ILyte Na, K, C1 System (28320)
Ionetics Model 400/450 Electrolyte Analyzer (28324)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Nova 10 (with CRT) (43061)
Nova 16 (43103)
Nova Stat Profile 9 (43086)
Nova Stat Profile Plus 10 (43063)
Olympus AU 5041 (46145)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Radiometer ABL 620 (55137)
Radiometer EML 100 (55134)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Synermed IR 500 (58322)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Chloride, Sweat (Cystic Fibrosis Sweat Test) (1019)
TEST SYSTEM, ASSAY OR EXAMINATION:
Scandipharm CF Indicator (9800) (58240)
ANALYTE: Cholesterol (1020)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
StatChem StatTest Sysem (58269)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Cholinesterase (1021)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 911 (07377)
Boehringer Mannheim Hitachi 914 (07546) [[Page 25954]]
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
Technicon Chem 1 (61003)
Technicon Chem 1 Plus (61036)
ANALYTE: Creatine Kinase (CK) (1034)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
Olympus AU 5121 (46087)
Olympus AU 5200 (46143)
PB Diagnostics Systems OPUS (49001)
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS PLUS (49098)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Creatine Kinase MB Fraction (CKMB) (1002)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott AxSYM (04532)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont ACA Star with aca plus Immunoassay System (13358)
Du Pont Dimension XL (13355)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II 34057)
LSI ASCA Chemistry System (37069)
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS PLUS (49098)
Princeton BioMeditech AccuSign MI CK-MB/Myoglobin (49143)
Princeton BioMeditech CarePoint MI CK-MB/Myoglobin (49141)
Princeton BioMeditech LifeSign MI CK-MB/Myoglobin (49140)
Princeton BioMeditech VitalSign MI CK-MB/Myoglobin (49142)
Sanofi Pasteur Access Immunoassay System (58257)
ANALYTE: Creatinine (1035)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Beckman Synchron CX 3 Delta (07548)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Nova 16 (43103)
Olympus AU 5041 (46145)
Olympus AU 5121 (46087)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Synermed IR 500 (58322)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Ferritin (1902)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott AxSYM (04532)
Bio-Rad RADIAS System (07493)
Boehringer Mannheim ES 300 AL (07524)
Cirrus Diagnostics Immulite (10159)
Du Pont ACA III with aca plus Immunoassay System (13253)
Du Pont ACA IV with aca plus Immunoassay System (13254)
Du Pont ACA Star with aca plus Immunoassay System (13358)
Du Pont ACA V with aca plus Immunoassay System (13255)
Olympus Reply (46089)
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS PLUS (49098)
Roche Cobas Core (55119)
Roche Cobas FARA (55040)
Roche Cobas FARA II (55041)
Roche Cobas Mira Plus (55096)
Sanofi Pasteur Access Immunoassay System (58257)
Seradyn LPIA-100 (58294)
Syva Vista Immunoassay System (58221)
Vitek Systems Vidas (67038)
ANALYTE: Folate (Folic acid) (1907)
TEST SYSTEM, ASSAY OR EXAMINATION:
Bio-Rad RADIAS System (07493)
Boehringer Mannheim Hitachi 911 (07377)
Cirrus Diagnostics Immulite (10159)
Roche Cobas Mira Plus (55096)
Sanofi Pasteur Access Immunoassay System (58257)
Syva Vista Immunoassay System (58221)
ANALYTE: Folate, Red Blood Cell (RBC Folate) (1930)
TEST SYSTEM, ASSAY OR EXAMINATION:
Ciba Corning ACS 180 (10046)
Sanofi Pasteur Access Immunoassay System (58257)
ANALYTE: Fructosamine (1914)
TEST SYSTEM, ASSAY OR EXAMINATION:
Boehringer Mannheim Hitachi 736 (07164)
Boehringer Mannheim Hitachi 914 (07546)
ANALYTE: Gamma Glutamyl Transferase (GGT) (2201)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Glucose (2203)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abaxis EPOC 2000 (04547)
Abbott Spectrum CCX (04515)
Beckman Synchron CX 3 Delta (07548)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Cholestech L.D.X. (10170)
Ciba Corning 860 (10269)
Ciba Corning 865 (10298)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
I-STAT i-STAT 200 System (28344)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Nova 16 (43103)
Nova Stat Profile 9 (43086)
Nova Stat Profile Plus 10 (43063)
Nova Stat Profile Ultra 11P Analyzer (43101)
Olympus AU 5041 (46145)
Olympus AU 5121 (46087)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
StatChem StatTest System (58269) [[Page 25955]]
Synermed IR 500 (58322)
Technicon OPERA Clinical Chemistry System (61161)
Yellow Springs YSI Model 23A Blood Glucose Analyzer (76006)
ANALYTE: Glycosylated Hemoglobin (Hgb A1C) (2204)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott IMX (04056)
Beckman Synchron CX 4 (07071)
Beckman Synchron CX 5 (07072)
Beckman Synchron CX 7 (07073)
Bio-Rad RADIAS System (07493)
Bio-Rad Variant (07498)
Boehringer Mannheim Hitachi 704 (07161)
Boehringer Mannheim Hitachi 717 (07163)
Boehringer Mannheim Hitachi 747 (07166)
Boehringer Mannheim Hitachi 911 (07377)
Boehringer Mannheim Hitachi 914 (07546)
Roche Cobas FARA (55040)
Roche Cobas Mira (55044)
ANALYTE: HDL Cholesterol (2550)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum (DMA One Shots) (04598)
Abbott Spectrum (MHS SPINPRO) (04563)
Abbott Spectrum (T-Am. Singles) (04588)
Abbott Spectrum CCX (DMA One Shots) (04599)
Abbott Spectrum CCX (T-Am. Singles) (04587)
Abbott Spectrum EPX (DMA One Shots) (04600)
Abbott Spectrum EPX (MHS SPINPRO) (04564)
Abbott Spectrum EPX (T-Am. Singles) (04565)
Abbott Spectrum Series II (DMA One Shots) (04601)
Abbott Spectrum Series II (MHS SPINPRO) (04566)
Abbott Spectrum Series II (T-Am. Singles) (04589)
Abbott Spectrum Series II CCX (DMA One Shots) (04602)
Abbott Spectrum Series II CCX (MHS SPINPRO) (04567)
Abbott Spectrum Series II CCX (T-Am. Singles) (04590)
Abbott TDX (04071)
Abbott TDX (MHS SPINPRO) (04568)
Abbott TDX FLx (04072)
Abbott TDX FLx (MHS SPINPRO) (04569)
Abbott VP (DMA One Shots) (04603)
Abbott VP (MHS SPINPRO) (04570)
Abbott Vision, Non Whole Blood HDL Procedure (04451)
Abbott Vision, Non Whole Blood HDL Procedure (MHS SPINPRO)
(04571)
Ames Seralyzer (DMA One Shots) (04604)
Ames Seralyzer III (DMA One Shots) (04605)
Baxter Paramax (DMA One Shots) (07618)
Baxter Paramax (MHS SPINPRO) (07566)
Baxter Paramax 720 ZX (DMA One Shots) (07619)
Baxter Paramax 720 ZX (MHS SPINPRO) (07567)
Beckman Astra 8 (MHS SPINPRO) (07568)
Beckman Astra 8e (MHS SPINPRO) (07569)
Beckman Astra Ideal (MHS SPINPRO) (07570)
Beckman Synchron AS-X (MHS SPINPRO) (07571)
Beckman Synchron AS-Xe (MHS SPINPRO) (07572)
Beckman Synchron AS Xi (MHS SPINPRO) (07573)
Beckman Synchron CX 4 (DMA One Shots) (07620)
Beckman Synchron CX 4 (MHS SPINPRO) (07574)
Beckman Synchron CX 4 CE (DMA One Shots) (07621)
Beckman Synchron CX 4 CE (MHS SPINPRO) (07575)
Beckman Synchron CX 5 (DMA One Shots) (07622)
Beckman Synchron CX 5 (MHS SPINPRO) (07576)
Beckman Synchron CX 5 (T-Am. Singles) (07577)
Beckman Synchron CX 5 CE (DMA One Shots) (07623)
Beckman Synchron CX 7 (DMA One Shots) (07624)
Beckman Synchron CX 7 (MHS SPINPRO) (07578)
Beckman Synchron CX 7 (T-Am. Singles) (07579)
Bio-Chem Laboratory Systems ATAC 2000/2100 (DMA One Shots)
(07634)
Bio-Chem Laboratory Systems ATAC 6000 (DMA One Shots) (07626)
Bio-Chem Laboratory Systems ATAC 6000 (T-Am. Singles) (07596)
BioAutoMed ASCA (07192)
BioAutoMed ASCA (DMA One Shots) (07625)
Boehringer Mannheim Hitachi 704 (DMA One Shots) (07627)
Boehringer Mannheim Hitachi 704 (MHS SPINPRO) (07580)
Boehringer Mannheim Hitachi 704 (T-Am. Singles) (07590)
Boehringer Mannheim Hitachi 705 (DMA One Shots) (07628)
Boehringer Mannheim Hitachi 705 (MHS SPINPRO) (07581)
Boehringer Mannheim Hitachi 705 (T-Am. Singles) (07591)
Boehringer Mannheim Hitachi 717 (DMA One Shots) (07629)
Boehringer Mannheim Hitachi 717 (MHS SPINPRO) (07582)
Boehringer Mannheim Hitachi 717 (T-Am. Singles) (07592)
Boehringer Mannheim Hitachi 736 (DMA One Shots) (07630)
Boehringer Mannheim Hitachi 736 (MHS SPINPRO) (07583)
Boehringer Mannheim Hitachi 736 (T-Am. Singles) (07593)
Boehringer Mannheim Hitachi 737 (DMA One Shots) (07631)
Boehringer Mannheim Hitachi 737 (MHS SPINPRO) (07584)
Boehringer Mannheim Hitachi 737 (T-Am. Singles) (07594)
Boehringer Mannheim Hitachi 747 (DMA One Shots) (07632)
Boehringer Mannheim Hitachi 747 (MHS SPINPRO) (07585)
Boehringer Mannheim Hitachi 747 (T-Am. Singles) (07595)
Boehringer Mannheim Hitachi 911 (MHS SPINPRO) (07586)
Ciba Corning 550 Express (DMA One Shots) (10291)
Ciba Corning 550 Express (MHS SPINPRO) (10274)
Ciba Corning 550 Express (T-Am. Singles) (10273)
Ciba Corning 570 Alliance (MHS SPINPRO) (10275)
Ciba Corning 580 Alliance (MHS SPINPRO) (10276)
Coulter Dacos (DMA One Shots) (10292)
Coulter Dacos (T-Am. Singles) (10277)
Coulter Optichem (T-Am. Singles) (10278)
Coulter Optichem 100 (DMA One Shots) (10293)
Du Pont ACA (DMA One Shots) (13365)
Du Pont ACA (MHS SPINPRO) (13346)
Du Pont ACA II (DMA One Shots) (13366)
Du Pont ACA II (MHS SPINPRO) (13347)
Du Pont ACA III (DMA One Shots) (13367)
Du Pont ACA III (MHS SPINPRO) (13348)
Du Pont ACA IV (DMA One Shots) (13368)
Du Pont ACA IV (MHS SPINPRO) (13349)
Du Pont ACA V (DMA One Shots) (13369)
Du Pont ACA V ((MHS SPINPRO) (13350)
Du Pont Analyst (DMA One Shots) (13364)
Du Pont Analyst (MHS SPINPRO) (13351)
Du Pont Dimension (DMA One Shots) (13370)
Du Pont Dimension (MHS SPINPRO) (13352)
Du Pont Dimension AR (DMA One Shots) (13371)
Du Pont Dimension AR (MHS SPINPRO) (13353)
Du Pont Dimension ES (DMA One Shots) (13372)
Du Pont Dimension ES (MHS SPINPRO) (13354)
EM Diagnostic Systems EPOS (DMA One Shots) (16099)
EM Diagnostic Systems EPOS (MHS SPINPRO) (16094)
Electronucleonics Gem-Profiler (DMA One Shots) (16095)
Electronucleonics Gemini (DMA One Shots) (16096)
Electronucleonics Gemstar (DMA One Shots) (16097)
Electronucleonics Gemstar (T-Am. Singles) (16093)
Electronucleonics Gemstar II (DMA One Shots) (16098)
Instrumentation Laboratory IL Monarch (T-Am. Singles) (28361)
Instrumentation Laboratory IL Monarch 1000 (DMA One Shots)
(28380)
Instrumentation Laboratory IL Monarch 1000 (T-Am. Singles)
(28362)
Instrumentation Laboratory IL Monarch 2000 (DMA One Shots)
(28381)
Instrumentation Laboratory IL Monarch 2000 (T-Am. Singles)
(28363)
Instrumentation Laboratory IL Monarch Plus (DMA One Shots)
(28382)
Instrumentation Laboratory IL Monarch Plus (T-Am. Singles)
(28364)
Kodak Ektachem 250 (DMA One Shots) (34076)
Kodak Ektachem 250 (MHS SPINPRO) (34063)
Kodak Ektachem 400 (DMA One Shots) (34077)
Kodak Ektachem 400 (MHS SPINPRO) (34064)
Kodak Ektachem 500 (DMA One Shots) (34078)
Kodak Ektachem 500 (MHS SPINPRO) (34065)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 550 XRC Analyzer (DMA One Shots)
(34079) [[Page 25956]]
Kodak Ektachem 700 (DMA One Shots) (34080)
Kodak Ektachem 700 (MHS SPINPRO) (34066)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 700 Analyzer C Series (DMA One Shots) (34081)
Kodak Ektachem 700 P (DMA One Shots) (34082)
Kodak Ektachem 700 P (MHS SPINPRO) (34067)
Kodak Ektachem 700 XR (DMA One Shots) (34083)
Kodak Ektachem 700 XR (MHS SPINPRO) (34068)
Kodak Ektachem 750 XRC (DMA One Shots) (34084)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT 60 (DMA One Shots) (34085)
Kodak Ektachem DT 60 (MHS SPINPRO) (34069)
Kodak Ektachem DT II (34057)
Kodak Ektachem DT II (DMA One Shots) (34086)
LSI ASCA Chemistry System (37069)
LSI ASCA Chemistry System (DMA One Shots) (37096)
LSI ASCA Chemistry System (T-Am. Singles) (37095)
Olympus AU 5000 (DMA One Shots) (46173)
Olympus AU 5021 (DMA One Shots) (46174)
Olympus AU 5031 (DMA One Shots) (46175)
Olympus AU 5041 (DMA One Shots) (46176)
Olympus AU 5061 (DMA One Shots) (46177)
Olympus AU 5121 (DMA One Shots) (46178)
Olympus AU 5131 (DMA One Shots) (46179)
Olympus AU 5200 (DMA One Shots) (46180)
Olympus AU 5211 (DMA One Shots) (46181)
Olympus AU 5221 (DMA One Shots) (46182)
Olympus AU 5223 (DMA One Shots) (46183)
Olympus AU 5231 (DMA One Shots) (46184)
Olympus AU 800 (DMA One Shots) (46185)
Olympus AU 5000 (MHS SPINPRO) (46161)
Olympus AU 5000 (T-Am. Singles) (46166)
Olympus Demand (DMA One Shots) (46186)
Olympus Demand (MHS SPINPRO) (46162)
Olympus Demand (T-Am. Singles) (46164)
Olympus Reply (DMA One Shots) (46187)
Olympus Reply (MHS SPINPRO) (46163)
Olympus Reply (T-Am. Singles) (46165)
Olympus Reply/AU560 (DMA One Shots) (46188)
PrismaSystems PROCHEM (49105)
Roche Cobas Bio (DMA One Shots) (55152)
Roche Cobas Bio (MHS SPINPRO) (55140)
Roche Cobas Bio (T-Am. Singles) (55143)
Roche Cobas FARA (DMA One Shots) (55153)
Roche Cobas FARA II (DMA One Shots) (55154)
Roche Cobas Fara (MHS SPINPRO) (55141)
Roche Cobas Fara (T-Am. Singles) (55144)
Roche Cobas MIRA (DMA One Shots) (55155)
Roche Cobas MIRA Plus (DMA One Shots) (55156)
Roche Cobas MIRA S (DMA One Shots) (55157)
Roche Cobas Mira (MHS SPINPRO) (55142)
Roche Cobas Mira (T-Am. Singles) (55145)
Schiapparelli Biosystems ACE (DMA One Shots) (58357)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Technicon Assist (DMA One Shots) (61181)
Technicon RA 100 (DMA One Shots) (61182)
Technicon RA 1000 (DMA One Shots) (61183)
Technicon RA 1000 (MHS SPINPRO) (61162)
Technicon RA 1000 (T-Am. Singles) (61164)
Technicon RA 2000 (DMA One Shots) (61184)
Technicon RA 500 (DMA One Shots) (61185)
Technicon RA 500 (T-Am. Singles) (61163)
Technicon RA XT (DMA One Shots) (61186)
Technicon RA XT (T-Am. Singles) (61165)
ANALYTE: Haptoglobin (2511)
TEST SYSTEM, ASSAY OR EXAMINATION
Behring Nephelometer II (07563)
ANALYTE: Hemoglobin S (2536)
TEST SYSTEM, ASSAY OR EXAMINATION:
Histo-Med Sickle Cell Reagent Set (25164)
ANALYTE: Iron (2814)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT SC Module (34017)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Iron Binding Capacity, Unsat. (UIBC) no pretreat. (2823)
TEST SYSTEM, ASSAY OR EXAMINATION:
Boehringer Mannheim Hitachi 914 (07546)
ANALYTE: Lactate Dehydrogenase (LDH) (3701)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
Olympus AU 5121 (46087)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Synermed IR 500 (58322)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Lactate Dehydrogenase Heart Fraction (LDH-1) (3702)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
ANALYTE: Lactate Dehydrogenase Liver Fraction (LLDH) 3703)
TEST SYSTEM, ASSAY OR EXAMINATION:
Du Pont ACA Star (13357)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
ANALYTE: Lactic Acid (Lactate) (3704)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Ciba Corning 860 (10269)
Ciba Corning 865 (10298)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
Nova Stat Profile 9 (43086)
Nova Stat Profile Plus 10 (43063)
Nova Stat Profile Ultra 11P Analyzer (43101)
Technicon OPERA Clinical Chemistry System (61161)
Yellow Springs YSI Model 23L Blood Lactoat Analyzer (76007)
ANALYTE: Lactoferrin (3727)
TEST SYSTEM, ASSAY OR EXAMINATION:
TechLab LEUKO-TEST (61133)
Touch Scientific LactoCard Tear Lactoferrin Immunoassay
(61110) [[Page 25957]]
Touch Scientific Lactoferrin MicroAssay System (61137)
ANALYTE: Leucine Aminopeptidase (LAP) (3709)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 5 CE (07491)
ANALYTE: Lipase (3711)
TEST SYSTEM, ASSAY OR EXAMINATION:
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT 60 (34016)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
ANALYTE: Magnesium (4002)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Nova 8 (43022)
Olympus AU 5041 (46145)
Olympus AU 5121 (46087)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Technicon Chem 1 Plus (61036)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Magnesium, Ionized (4018)
TEST SYSTEM, ASSAY OR EXAMINATION:
AVL 988-4 (04556)
Nova Stat Profile Ultra 11P Analyzer (43101)
ANALYTE: Methemoglobin (4032)
TEST SYSTEM, ASSAY OR EXAMINATION:
Ciba Corning 845 (10296)
Ciba Corning 855 (10297)
Ciba Corning 865 (10298)
ANALYTE: Microalbumin (4019)
TEST SYSTEM, ASSAY OR EXAMINATION:
Boehringer Mannheim Hitachi 747 (07166)
Boehringer Mannheim Hitachi 911 (07377)
ANALYTE: Microprotein, CSF (4026)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 4 CE (07174)
Beckman Synchron CX 5 CE (07491)
Beckman Synchron CX 7 (07073)
Boehringer Mannheim Hitachi 914 (07546)
Olympus AU 5041 (46145)
Olympus AU 800 (46110)
ANALYTE: Microprotein, Urine (4027)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 4 CE (07174)
Beckman Synchron CX 5 CE (07491)
Beckman Synchron CX 7 (07073)
Boehringer Mannheim Hitachi 914 (07546)
Olympus AU 5041 (46145)
Olympus AU 800 (46110)
ANALYTE: Myoglobin (4023)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelometer II (07563)
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS PLUS (49098)
Princeton BioMeditech AccuSign MI CK-MB/Myoglobin (49143)
Princeton BioMeditech CarePoint MI CK-MB/Myoglobin (49141)
Princeton BioMeditech LifeSign MI CK-MB/Myoglobin (49140)
Princeton BioMeditech LifeSign MI Myoglobin (49122)
Princeton BioMeditech VitalSign MI CK-MB/Myoglobin (49142)
ANALYTE: Osmolality, Serum (4602)
TEST SYSTEM, ASSAY OR EXAMINATION:
Advanced Instruments Model 3D3 Osmometer (04520)
ANALYTE: Osmolality, Urine (4603)
TEST SYSTEM, ASSAY OR EXAMINATION:
Advanced Instruments Model 3D3 Osmometer (04520)
ANALYTE: Oxyhemoglobin/Oxygen Saturation (4604)
TEST SYSTEM, ASSAY OR EXAMINATION:
Ciba Corning 845 (10296)
Ciba Corning 855 (10297)
Ciba Corning 865 (10298)
Radiometer ABL 620 (55137)
ANALYTE: Phosphorus (4906)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont ACA Dimension XL (13355)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
Olympus AU 5121 (46087)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Synermed IR 500 (58322)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Potassium (4910)
TEST SYSTEM, ASSAY OR EXAMINATION:
AVL 988-4 (04556)
American Monitor Parallel (04144)
Beckman Synchron CX 3 Delta (07548)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Ciba Corning 850 (10251)
Ciba Corning 855 (10297)
Ciba Corning 860 (10269)
Ciba Corning 865 (10298)
Diametrics Medical IRMA Blood Analysis System (13362)
Du Pont Dimension XL (13355)
I-STAT i-STAT 200 System (28344)
Instrumentation Laboratory Blood Gas 1630 (28337)
Instrumentation Laboratory Blood Gas 1640 (28338)
Instrumentation Laboratory Blood Gas 1650 (28339)
Instrumentation Laboratory IL 1430 BGElectrolyte (28343)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Instrumentation Laboratory ILye Na, K, Cl System (28320)
Instrumentation Laboratory ILye Na, K, Li System (28319)
Ionetics Model 400/450 Electrolyte Analyzer (28324)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
Medica EasyLyte Calcium Analyzer (40197)
Nova 10 (with CRT) (43061)
Nova 16 (43103)
Nova 8 (43022)
Nova Stat Profile 9 (43086)
Nova Stat Profile Plus 10 (43063)
Nova Stat Profile Ultra 11P Analyzer (43101)
Olympus AU 5041 (46145)
Olympus AU 5200 (46143)
PDX Stat K Rapid Potassium Test System (49102)
PrismaSystems PROCHEM (49105)
Radiometer ABL 620 (55137)
Radiometer EML 100 (55134)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
StatChem StatTest Sysem (58269)
Synermed IR 500 (58322)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Prealbumin (4911)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelometer II (07563)
'ANALYTE: Prostatic Acid Phosphatase (PAP) (4918) [[Page 25958]]
TEST SYSTEM, ASSAY OR EXAMINATION:
Cirrus Diagnostics Immulite (10159)
ANALYTE: Prostatic Specific Antigen (PSA) (4919)
TEST SYSTEM, ASSAY OR EXAMINATION:
TOSOH A1A-1200 (61040)
ANALYTE: Protein, Total (4921)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abaxis EPOC 2000 (04547)
Abott Spectrum CCX (04515)
Beckman Synchron CX 3 Delta (07548)
Beckman Synchron CX 4 CE (07174)
Beckman Synchron CX 5 CE (07491)
Behring Nephelometer II (07563)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
Olympus AU 5121 (46087)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Synermed IR 500 (58322)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Protein, Total (urine) (4972)
TEST SYSTEM, ASSAY OR EXAMINATION:
Du Pont ACA Star (13357)
Du Pont Dimension (13086)
Du Pont Dimension AR (13087)
Du Pont Dimension ES (13215)
Du Pont Dimension XL (13355)
ANALYTE: Pseudocholinesterase (4923)
TEST SYSTEM, ASSAY OR EXAMINATION:
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
ANALYTE: Reduced Hemoglobin (5523)
TEST SYSTEM, ASSAY OR EXAMINATION:
Ciba Corning 845 (10296)
Ciba Corning 855 (10297)
Ciba Corning 865 (10298)
ANALYTE: Retinol binding protein (5507)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelometer II (07563)
ANALYTE: Sodium (5805)
TEST SYSTEM, ASSAY OR EXAMINATION:
AVL 988-4 (04556)
Abbott Vision (04083)
American Monitor Parallel (04144)
Beckman Synchron CX 3 Delta (07548)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Ciba Corning 850 (10251)
Ciba Corning 855 (10297)
Ciba Corning 860 (10269)
Ciba Corning 865 (10298)
Diametrics Medical IRMA Blood Analysis System (13362)
Du Pont Dimension XL (13355)
I-STAT i-STAT 200 System (28344)
Instrumentation Laboratory Blood Gas 1630 (28337)
Instrumentation Laboratory Blood Gas 1640 (28338)
Instrumentation Laboratory Blood Gas 1650 (28339)
Instrumentation Laboratory IL 1430 BGElectrolyte (28343)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Instrumentation Laboratory ILyte Na, K, Cl System (28320)
Instrumentation Laboratory ILyte Na, K, Li System (28319)
Ionetics Model 400/450 Electrolyte Analyzer (28324)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
Medica EasyLyte Calcium Analyzer (40197)
Nova 10 (with CRT) (43061)
Nova 16 (43103)
Nova 8 (43022)
Nova Stat Profile 9 (43086)
Nova Stat Profile Plus 10 (43063)
Nova Stat Profile Ultra 11P Analyzer (43101)
Olympus AU 5041 (46145)
Olympus AU 5200 (46143)
Radiometer ABL 620 (55137)
Radiometer EML 100 (55134)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Synermed IR 500 (58322)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Total Solids (Protein) (6131)
TEST SYSTEM, ASSAY OR EXAMINATION:
ATAGO A300CL Clinincal Refractometer (04575)
ATAGO N Serum Protein Refractometer (04574)
ATAGO SP-D Digital Serum Protein Refractometer (04579)
ATAGO T-2 Clinical Refractometer (04577)
National Instrument Hand Protometer (43085)
ANALYTE: Transferrin (6114)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelometer II (07563)
Boehringer Mannheim Hitachi 911 (07377)
Boehringer Mannheim Hitachi 914 (07546)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Triglyceride (6118)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Beckman Synchron CX 4 CE (07174)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
Olympus AU 5121 (46087)
Olympus AU 5200 (46143)
PrismaSystems Prochem (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Troponin T (Tn T) (6140)
TEST SYSTEM, ASSAY OR EXAMINATION:
Boehringer Mannheim ES 300 (07160)
ANALYTE: Urea (BUN) (6403)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Spectrum CCX (04515)
Beckman Synchron CX 3 Delta (07548)
Beckman Synchron CX 4 CE (07174)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
I-STAT i-STAT 200 System (28344)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Nova 16 (43103)
Nova Stat Profile Plus 10 (43063)
Olympus AU 5041 (46145)
Olympus AU 5121 (46087)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Synermed IR 500 (58322)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Uric Acid (6404)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abaxis EPOC 2000 (04547)
Abbott Spectrum CCX (04515)
Beckman Synchron CX 4 CE (07174)
Beckman Synchron CX 5 CE (07491)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355) [[Page 25959]]
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 900 (28322)
Kodak Ektachem 550 XRC Analyzer (34056)
Kodak Ektachem 700 Analyzer C Series (34054)
Kodak Ektachem 750 XRC Analyzer (34055)
Kodak Ektachem 950 IRC (34087)
Kodak Ektachem DT II (34057)
LSI ASCA Chemistry System (37069)
Olympus AU 5041 (46145)
Olympus AU 5200 (46143)
PrismaSystems PROCHEM (49105)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Vitamin B12 (6707)
TEST SYSTEM, ASSAY OR EXAMINATION:
Bio-Rad RADIAS System (97493)
Roche Cobas Mira Plus (55096)
Sanofi Pasteur Access Immunoassay System (58257)
Syva Vista Immunoassay System (58221)
Technicon Immuno 1 System (61042)
SPECIALITY/SUBSPECIALITY: General Immunology
ANALYTE: Allergen specific IgE (0417)
TEST SYSTEM, ASSAY OR EXAMINATION:
Cirrus Diagnostic Immulite (10159)
In Vitro Technologies Allergy Profile (28279)
Sanofi Pasteur Access Immunoassay System (58257)
ANALYTE: Alpha-1 Microglobin (0470)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Array 360 (07052)
Behring Nephelometer II (07563)
ANALYTE: Alpha-1-Acid Glycoprotein (orosomucoid) (0420)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelometer II (07563)
Alpha-1-Antitrypsin (0421)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelomoter II (07563)
ANALYTE: Alpha-2 Macroglobulin (0422)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelometer II (07563)
ANALYTE: Alpha-Fetoprotein--Tumor Marker (0424)
TEST SYSTEM, ASSAY OR EXAMINATION:
Boehringer Mannheim ES 300 AL (07524)
ANALYTE: Anti-Nuclear Antibodies (ANA) (0441)
TEST SYSTEM, ASSAY OR EXAMINATION:
Bio-Rad Radias System (07493)
J & S Medical Accutex SLE Latex Test (31002)
ANALYTE: Anti-Streptolysin O (ASO) (0452)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 5 CE (07491)
Behring Nephelometer II (07563)
J & S Medical Accutex Antistreptolysin O (ASO) Latex Text
(31006)
ANALYTE: Beta-2 microglobulin (0703)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Array 360 (07052)
Cirrus Diagnostics Immulite (10159)
Du Pont ACA Star (13357)
Du Pont ACA V (13084)
Wallac Oy AutoDELFIA (70167)
ANALYTE: C-Reactive Protein (CRP) (1001)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 5 CE (07491)
Behring Nephelometer II (07563)
Boehringer Mannheim Hitachi 747 (07166)
Boehriner Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Du Pont Dimension XL (13355)
Immunostics immuno/crp Test (28277)
J & S Medical Accutex C-Reactive Protein (CRP) Latex Text
(31004)
J & S Medical Eye Spot CRP test (31007)
Pulse Scientific C-Reactive Protein (CRP) Test (49075)
Technicon OPERA Clinical Chemistry System (61161
ANALYTE: Complement C3 (1029)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelometer II (07563)
Boehringer Mannheim Hitachi 914 (07546)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Complement C4 (1030)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelometer II (07563)
Boehringer Mannheim Hitachi 914 (07546)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Cytomegalovirus Antibodies (1039)
TEST SYSTEM, ASSAY OR EXAMINATION:
PB Diagnostics System OPUS (49001)
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS PLUS (49098)
Vitek Systems Vidas (67038)
ANALYTE: Helicobacter Pylori Antibodies (2513)
TEST SYSTEM, ASSAY OR EXAMINATION:
Meridian Diagnostics ImmunoCard H. pylori (40195)
SmithKline FlexSure HP Test (58321)
ANALYTE: Hemopexin (2517)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelometer II (07563)
ANALYTE: Hepatitis A Virus Antibody (2519)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott IMX (04056)
ANALYTE: Immunoglobulins IgA (2803)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 5 CE (07491)
Behring Nephelometer II (07563)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Immunoglobulins IgE (2805)
TEST SYSTEM, ASSAY OR EXAMINATION:
Boehringer Mannheim ES 300 AL (07524)
Cirrus Diagnostics Immulite (10159)
Roche Cobas Core (55119)
Sanofi Pasteur Access Immunoassay System (58257)
Vitek Systems Vidas (67038)
ANALYTE: Immunoglobulins IgG (2806)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 5 CE (07491)
Behring Nephelometer II (07563)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Immunoglobulins IgG subclasses (2807)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelometer (07273)
Behring Nephelometer 100 (07272)
ANALYTE: Immunoglobulins IgM (2808)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 5 CE (07491)
Behring Nephelometer II (07563)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Technicon OPERA Clinical Chemistry System (61161)
ANALYTE: Infectious Mononucleosis Antibodies (Mono) (2809)
TEST SYSTEM, ASSAY OR EXAMINATION:
Immunostics immuno/im test (28278)
J & S Medical Accutex Inf. Mono. Red Bld. Cell (IM RBC) Test
(31003)
J & S Medical Accutex Infectious Mononucleosis Latex Test
(31008)
J & S Medical Eye Spot Infectious Mononucleosis (IM) Test
(31013)
Meridian Diagnostics ImmunoCard Mono (40179)
Pacific Biotech Concise Plus Mono (49148)
Princeton BioMeditech BioSign Mono Test (49100)
ANALYTE: Kappa Light Chains (3402)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelometer II (07563)
ANALYTE: Lambda Light Chains (3705)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelometer II (07563)
ANALYTE: Mumps Antibodies (4007)
TEST SYSTEM, ASSAY OR EXAMINATION:
Vitek Systems Vidas (67038)
ANALYTE: Mycoplasma pneumoniae Antibodies (4016)
TEST SYSTEM, ASSAY OR EXAMINATION:
Meridian Diagnostics ImmunoCard Mycoplasma (40196)
Murex Mycoplasma pneumoniae Antibody Detection Kit (40175)
ANALYTE: Rheumatoid Factor (RF) (5508)
TEST SYSTEM, ASSAY OR EXAMINATION: [[Page 25960]]
Behring Nephelometer II (07563)
Immunostics immuno/undiluted ra Test (28275)
J & S Medical Accutex Rheumatoid Factor (RF) Latex Test (31005)
J & S Medical Eye Spot Rheumatoid Factor (RF) Test (31012)
Pulse Scientific Rheumatoid Factor (RF) Test (49101)
Trinity Laboratories RHEUMA-LEX System (61116)
ANALYTE: Rickettsia typhi Ab (Typhus Antibodies) (5514)
TEST SYSTEM, ASSAY OR EXAMINATION:
Integrated Diagnostics INDX DIP-S-TICKS R. typhi (28265)
ANALYTE: Rubella Antibodies (5510)
TEST SYSTEM, ASSAY OR EXAMINATION:
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS PLUS (49098)
Princeton BioMeditech BioSign Rubella (49121)
Wampole IMPACT Rubella Slide Test (70165)
ANALYTE: Rubeola Antibodies (measles) (5511)
TEST SYSTEM, ASSAY OR EXAMINATION:
Vitek Systems Vidas (67038)
ANALYTE: Toxoplasma gondii Antibodies (6113)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 5 CE (07491)
Biokit Toxogen (07494)
PB Diagnostics Systems OPUS (49001)
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS PLUS (49098)
Vitek Systems Vidas Toxo Competition (TXC) Assay (67080)
ANALTYE: Varicella-Zoster Virus Antibodies (6704)
TEST SYSTEM, ASSAY OR EXAMINATION:
Vitek Systems Vidas (67038)
SPECIALITY/SUBSPECIALITY: Hematology
ANALYTE: Activated Clotting Time (ACT) (0461)
TEST SYSTEM, ASSAY OR EXAMINATION:
HemoTec Automated Coagulation Timer High Range Heparinase
(25184)
HemoTec Automated Coagulation Timer II (25180)
HemoTec Automated Coagulation Timer II High Range Heparinase
(25185)
International Technidyne Hemochron 8000 (28298)
International Technidyne Hemochron Jr. Microcoagulation (28345)
ANALYTE: Activated Partial Thromboplastin Time (APTT) (0409)
TEST SYSTEM, ASSAY OR EXAMINATION:
American Bioproducts STA Analyzer (04594)
Behring Fibrintimer A (07516)
Cardiovascular Diagnostics TAS Analyzer (10257)
Helena Laboratories Cascade M (25156)
HemoTec Automated Coagulation Timer II (25180)
Instrumentation Laboratory MCL 2 Coagulation Analyzer (28297)
International Technidyne Factor VI Premier (28296)
International Technidyne Factor VI Premier SingleShot APTT
(28293)
International Technidyne Factor VI Premier Vacu-APTT (28295)
International Technidyne Factor VI SingleShot APTT (28292)
International Technidyne Factor VI Vacu-APTT (28294)
International Technidyne Hemochron 400 Cit. One-Step APTT
(28287)
International Technidyne Hemochron 400 Direct Draw APTT (28282)
International Technidyne Hemochron 401 Cit. One-Step APTT
(28288)
International Technidyne Hemochron 401 Direct Draw APTT (28283)
International Technidyne Hemochron 800 Cit. One-Step APTT
(28289)
International Technidyne Hemochron 800 Direct Draw APTT (28284)
International Technidyne Hemochron 8000 (28298)
International Technidyne Hemochron 8000 Cit. One-Step APTT
(28291)
International Technidyne Hemochron 8000 Direct Draw APTT (28286)
International Technidyne Hemochron 801 Cit. One-Step APTT
(28290)
International Technidyne Hemochron 801 Direct Draw APTT (28285)
International Technidyne Microsample Coagulation Analyzer
(28267)
Medical Laboratory MLA Electra 1600C (40167)
Organon Teknika Multi Channel Discrete Analyzer (MDA-180)
(46144)
TOA Medical Electronics CA-1000 (61132)
TOA Medical Electronics CA-5000 (61135)
Vitek HEMOLAB (67075)
ANALYTE: Antithrombin III (ATIII) (0456)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelometer II (07563)
Du Pont ACA Star (13357)
ANALYTE: Body Fluid Microscopic Elements (0716)
TEST SYSTEM, ASSAY OR EXAMINATION:
IRIS IRIScope Body Fld. Cell Count Sys. (RBC/WBC enum. only)
(28333)
ANALYTE: Capillary fragility (1093)
TEST SYSTEM, ASSAY OR EXAMINATION:
Capillary Fragility/Tourniquet Test (10247)
ANALYTE: Fibrin Monomers (1927)
TEST SYSTEM, ASSAY OR EXAMINATION:
Ethanol Gel; Protamine Sulfate (no serial dilutions) (16044)
ANALYTE: Fibrin Split Products (Fibrin Degradation) (1904)
TEST SYSTEM, ASSAY OR EXAMINATION:
Baxter Diagnostic Dimertest Latex Assay (07552)
Baxter Diagnostic FDP Detection Set (07551)
Du Pont ACA Star (13357)
Organon Teknika AuraTek FDP (46153)
Vitek FDP Slidex direct (67084)
ANALYTE: Fibrinogen (1905)
TEST SYSTEM, ASSAY OR EXAMINATION:
American Bioproducts STA Analyzer (04594)
Behring Nephelometer II (07563)
Du Pont ACA Star (13357)
Helena Laboratories Cascade M (25156)
Instrumentation Laboratory MCL 2 Coagulation Analyzer (28297)
International Technidyne Factor VI (28093)
International Technidyne Factor VI Premier (28296)
International Technidyne Hemochron 400 (28094)
International Technidyne Hemochron 401 (28095)
International Technidyne Hemochron 800 (28096)
International Technidyne Hemochron 8000 (28298)
International Technidyne Hemochron 801 (28097)
Medical Laboratory MLA Electra 1600C (40167)
TOA Medical Electronics CA-1000 (61132)
TOA Medical Electronics CA-5000 (61135)
Vitek HEMOLAB (67075)
ANALYTE: Hematocrit (2514)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Cell-Dyn 1700 (04607)
Abbott EnCounter (04525)
Alicia Diagnostic Genesis I (04536)
Coulter ONYX (10254)
Coulter ONYX with Autoloader (10281)
DMA H12 (13284)
Danam Datacell 16CP (13363)
Diametrics Medical IRMA Blood Analysis System (13362)
I-STAT i-STAT 200 System (28344)
Infolab I-1600 (28379)
Instrumentation Laboratory BGElectrolytes (28063)
Nova 16 (43103)
Nova Stat Profile 9 (43086)
Nova Stat Profile Plus 10 (43063)
Nova Stat Profile Ultra 11P Analyzer (43101)
Separation Technology STI HemataSTAT Model C70B (58310)
Sysmex K-4500 (58358)
Sysmex K-800 (58307)
Sysmex SE-9000 (58318)
Technalysis CELLEXIS Hematology Analyzer (61102)
Technicon H.3 RTC System (61103)
Technicon H. 3 RTX System (61104)
Texas International Laboratories H12 (61128)
ANALYTE: Hemoglobin (2515)
TEST SYSTEM, ASSAY OR EXAMINATION:
AVL 995 Hb (04021)
Abbott Cell-Dyn 1700 (04607)
Abbott EnCounter (04525)
Alicia Diagnostics Genesis I (04536)
Artel HbM Hemoglobinometer (04551)
Ciba Corning 280 (10036)
Ciba Corning 288 (10037)
Ciba Corning 845 (10296)
Ciba Corning 855 (10297)
Ciba Corning 865 (10298)
Coulter ONYX (10254) [[Page 25961]]
Coulter ONYX with Autoloader (10281)
DMA H12 (13284)
Danam Datacell 16CP (13363)
I-STAT i-STAT 200 System (28344)
Infolab I-1600 (28379)
Radiometer ABL 1 (55049)
Radiometer ABL 2 (55001)
Radiometer ABL 2 RA (55050)
Radiometer ABL 3 (55002)
Radiometer ABL 3 M (55051)
Radiometer ABL 300 (55004)
Radiometer ABL 4 (55006)
Radiometer ABL 510 (55054)
Radiometer ABL 520 (55055)
Separation Technology STI HemataSTAT Model C70B (58310)
StatChem StatTest System (58269)
Sysmex K-4500 (58358)
Sysmex K-800 (58307)
Sysmex SE-9000 (58318)
Technalysis CELLEXIS Hematology Analyzer (61102)
Technicon H.3 RTC System (61103)
Technicon H.3 RTX System (61104)
Texas International Laboratories H12 (61128)
ANALYTE: Heparin (2518)
TEST SYSTEM, ASSAY OR EXAMINATION:
Du Pont ACA Star (13357)
ANALYTE: Heparin Dose Response (HDR) (2539)
TEST SYSTEM, ASSAY OR EXAMINATION:
International Technidyne Factor VI (28093)
International Technidyne Hemochron 400 (28094)
International Technidyne Hemochron 401 (28095)
International Technidyne Hemochron 800 (28096)
International Technidyne Hemochron 8000 (28298)
International Technidyne Hemochron 801 (28097)
ANALYTE: Plasminogen (4907)
TEST SYSTEM, ASSAY OR EXAMINATION:
Behring Nephelometer II (07563)
Du Pont ACA Star (13357)
ANALYTE: Platelet Count (4908)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Cell-Dyn 1700 (04607)
Abbott EnCounter (04525)
Alicia Diagnostics Genesis I (04536)
Coulter ONYX (10254)
Coulter ONYX with Autoloader (10281)
DMA H12 (13284)
Danam Datacell 16CP (13363)
Infolab I-1600 (28379)
Sysmex K-4500 (58358)
Sysmex K-800 (58307)
Sysmex SE-9000 (58318)
Technalysis CELLEXIS Hematology Analyzer (61102)
Technicon H.3 RTC System (61103)
Technicon H.3 RTX System (61104)
Texas International Laboratories H12 (61128)
ANALYTE: Prothrombin Time (PT) (4922)
TEST SYSTEM, ASSAY OR EXAMINATION:
American Bioproducts STA Analyzer (04594)
Behring Fibrintimer A (07516)
Boehringer Mannheim CoaguChek System (07496)
Cardiovascular Diagnostics TAS Analyzer (10257)
Helena Laboratories Cascade M (25156)
HemoTec Automated Coagulation Timer II (25180)
Instrumentation Laboratory MCL 2 Coagulation Analyzer (28297)
International Technidyne Factor VI Jr. Microcoagulation (28346)
International Technidyne Factor VI Premier (28296)
International Technidyne Hemochron 8000 (28298)
International Technidyne Hemocrhon Jr. Microcoagulation (28345)
Medical Laboratory MLA Electra 1600C (40167)
Organon Teknika Multi Channel Discrete Analyzer (MDA-180)
(46144)
TOA Medical Electronics CA-1000 (61132)
TOA Medical Electronics CA-5000 (61135)
Vitek HEMOLAB (67075)
ANALYTE: Red Blood Cell Count (Erythrocyte Count) (RBC) (5502)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Cell-Dyn 1700 (04607)
Abbott EnCounter (04525)
Alicia Diagnostics Genesis I (04536)
Coulter ONYX (10254)
Coulter ONYX with Autoloader (10281)
DMA H12 (13284)
Danam Datacell 16CP (13363)
Infolab I-1600 (28379)
Sysmex K-4500 (58358)
Sysmex K-800 (58307)
Sysmex SE-9000 (58318)
Technalysis CELLEXIS Hematology Analyzer (61102)
Technicon H.3 RTC System (61103)
Technicon H.3 RTX System (61104)
Texas International Laboratories H12 (61128)
ANALYTE: Reticulocyte Count (5506)
TEST SYSTEM, ASSAY OR EXAMINATION:
Becton Dickinson FACSCAN (with retic count software) (07518)
Coulter MAXM (10078)
Coulter STKS (10093)
Technicon H.3 RTC System (61103)
Technicon H.3 RTX System (61104)
ANALYTE: Semen (5822)
TEST SYSTEM, ASSAY OR EXAMINATION:
IRIS IRIScope Body Fld. Cell Count Sys. (sperm enum. only)
(28334)
ANALYTE: Thrombin Time (6105)
TEST SYSTEM, ASSAY OR EXAMINATION:
American Bioproducts STA Analyzer (04594)
Helena Laboratories Cascade M (25156)
Instrumentation Laboratory MCL 2 Coagulation Analyzer (28297)
International Technidyne Factor VI Premier (28296)
International Technidyne Factor VI Preimer Throm. Time Plus
(28310)
International Technidyne Factor VI Thrombin Time Plus (28309)
International Technidyne Hemochron 400 HNTT (28299)
International Technidyne Hemochron 400 HiTT (28304)
International Technidyne Hemochron 401 HNTT (28300)
International Technidyne Hemochron 401 HiTT (28305)
International Technidyne Hemochron 800 HNTT (28301)
International Technidyne Hemochron 800 HiTT (28306)
International Technidyne Hemochron 8000 (28298)
International Technidyne Hemochron 8000 HNTT (28303)
International Technidyne Hemochron 8000 HiTT (28308)
International Technidyne Hemochron 801 HNTT (28302)
International Technidyne Hemochron 801 HiTT (28307)
Medical Laboratory MLA Electra 1600C (40167)
TOA Medical Electronics CA-1000 (61132)
TOA Medical Electronics CA-5000 (61135)
Vitek HEMOLAB (67075)
ANALYTE: White Blood Cell Count (Leukocyte Count) (WBC) (7002)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Cell-Dyn 1700 (04607)
Abbott EnCounter (04525)
Alicia Diagnostics Genesis I (04536)
Coulter ONYX (10254)
Coulter ONYX with Autoloader (10281)
DMA H12 (13284)
Danam Datacell 16CP (13363)
Infolab I-1600 (28379)
Sysmex K-4500 (58358)
Sysmex K-800 (58307)
Sysmex SE-9000 (58318)
Technalysis CELLEXIS Hematology Analyzer (61102)
Technicon H.3 RTC System (61103)
Technicon H.3 RTX (61104)
Texas International Laboratories H12 (61128)
ANALYTE: White Blood Cell Differential (WBC Diff) (7001)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott Cell-Dyn 1700 (04607)
Abbott EnCounter (04525)
Alicia Diagnostics Genesis I (04536)
Coulter ONYX (10254)
Coulter ONYX with Autoloader (10281)
DMA H12 (13284)
Danam Datacell 16CP (13363)
Infolab I-1600 (28379)
Sysmex K-4500 (58358)
Sysmex SE-9000 (58318)
Technalysis CELLEXIS Hematology Analyzer (61102)
Technicon H.3 RTC System (61103)
Technicon H.3 RTX System (61104)
Texas International Laboratories H12 (61128)
SPECIALITY/SUBSPECIALITY: Mycology
ANALYTE: Dermatophytes (1302)
TEST SYSTEM, ASSAY OR EXAMINATION:
Biomed Diagnostics InTray DM Medium (07559)
Troy Biologicals Dermatophyte Test Medium (61106)
ANALYTE: Yeast, Candida only (7603) [[Page 25962]]
TEST SYSTEM, ASSAY OR EXAMINATION:
MicroProbe Affirm VPIII Microbial Identification Test (40163)
SPECIALITY/SUBSPECIALITY: Parasitology
ANALYTE: Cryptosprodium (1109)
TEST SYSTEM, ASSAY OR EXAMINATION:
Alexon ProSpecT Cryptosporidum Rapid Assay (dir. Ag/vis.)
(04553)
ANALYTE: Giardia lamblia (2222)
TEST SYSTEM, ASSAY OR EXAMINATION:
Alexon ProSpecT Giardia Rapid Assay (direct antigen/visual)
(04364)
ANALYTE: Scabies (5831)
TEST SYSTEM, ASSAY OR EXAMINATION:
All Direct Wet Mount Preparations (04108)
ANALYTE: Trichomonas (6116)
TEST SYSTEM, ASSAY OR EXAMINATION:
MicroProbe Affirm VPIII Microbial Identification Test (40163)
SPECIALITY/SUBSPECIALITY: Toxicology/TDM
ANALYTE: Acetaminophen (0406)
TEST SYSTEM, ASSAY OR EXAMINATION:
Du Pont ACA Star (13357)
GDS Diagnostics Stat-Site Meter (22126)
ANALYTE: Amikacin (0425)
TEST SYSTEM, ASSAY OR EXAMINATION:
Du Pont ACA Star (13357)
ANALYTE: Amphetamines (0428)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 5 CE (07491)
Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt.
(07528)
Boehringer Mannheim Hitachi 911 (07377)
Boehringer Mannheim Hitachi 914 (07546)
Drug Screening Systems microLINE Screens (13259)
Du Pont ACA Star (13357)
Olympus AU 5041 (46145)
Olympus AU 5121 (46087)
Olympus AU 5200 (46143)
Princeton BioMeditech AbuSign DOA 4 (49130)
ANALYTE: Barbiturates (0701)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 5 CE (07491)
Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt.
(07528)
Boehringer Mannheim Hitachi 914 (07546)
Drug Screening Systems microLINE Screens (13259)
Du Pont ACA Star (13357)
Olympus AU 5041 (46145)
Olympus AU 5121 (46087)
Olympus AU 5200 (46143)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
ANALYTE: Benzodiazepines (0702)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 5 CE (07491)
Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt.
(07528)
Boehringer Mannheim Hitachi 914 (07546)
Drug Screening Systems microLINE Screens (13259)
Du Pont ACA Star (13357)
Olympus AU 5041 (46145)
Olympus AU 5121 (46087)
Olympus AU 5200 (46143)
ANALYTE: Cannabinoids (THC) (1009)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 5 CE (07491)
Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt.
(07528)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Olympus AU 5041 (46145)
Olympus AU 5121 (46087)
Olympus AU 5200 (46143)
Princeton BioMeditech AbuSign DOA 4 (49130)
Princeton BioMeditech AbuSign THC (49133)
Princeton BioMeditech AccuSign THC (49139)
Princeton BioMeditech BioSign THC (49137)
Princeton BioMeditech DOA-COC (49135)
Roche OnTrak TESTCUP Collection/Urinalysis Panel (55146)
ANALYTE: Carbamazepine (1010)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott AxSYM (04532)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
Instrumentation Laboratory ILAB 1800 (28323)
Instrumentation Laboratory ILAB 1800 (28322)
PB Diagnostics Systems OPUS Magnum (49097)
PB Diagnostics Systems OPUS Magnum (49098)
Seradyn LPIA-100 (58294)
ANALYTE: Carboxyhemoglobin (1012)
TEST SYSTEM, ASSAY OR EXAMINATION:
Ciba Corning 845 (10296)
Ciba Corning 855 (10297)
Ciba Corning 865 (10298)
Radiometer ABL 620 (55137)
ANALYTE: Cocaine Metabolites (1023)
TEST SYSTEM, ASSAY OR EXAMINATION:
Beckman Synchron CX 5 CE (07491)
Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt.
(07528)
Boehringer Mannheim Hitachi 911 (07377)
Boehringer Mannheim Hitachi 914 (07546)
Du Pont ACA Star (13357)
EDITEK VERDICT COCAINE (16078)
Olympus AU 5041 (46145)
Olympus AU 5121 (46087)
Olympus AU 5200 (46143)
Princeton BioMeditech AbuSign COC (49132)
Princeton BioMeditech AbuSign DOA 4 (49130)
Princeton BioMeditech AccuSign COC (49138)
Princeton BioMeditech BioSign COC (49136)
Princeton BioMeditech DOA-TCO (49134)
Roche OnTrak TESTCUP Collection/Urinalysis Panel (55146)
Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
ANALYTE: Digitoxin (1303)
TEST SYSTEM, ASSAY OR EXAMINATION:
Cirrus Diagnostics Immulite (10159)
Du Pont ACA Star (13357)
ANALYTE: Digoxin (1304)
TEST SYSTEM, ASSAY OR EXAMINATION:
Abbott AxSYM (04532)
Beckman Synchron CX 4 CE (07174)
Beck |