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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2001 Biological Device Application Approvals

This list reflects information regarding the applications as of the approval date; it is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval.


Tradename Description and Indication for Device Applicant Number Approval Date
Calypte HIV-1 Urine EIA HIV detection test used in professional laboratory settings as an aid in clinical diagnosis of HIV infection Calypte Biomedical Corp
1440 Fourth Street
Berkeley, CA 94710
BP000009 1/12/2001
UniTray SSP HLA Typing Kits HLA typing kits used for resolution of HLA Class I and/or Class II loci Pel-Freez Clinical Systems, LLC
9099 N. Deerbrook Trail
Brown Deer, WI 53223
BK000019 1/29/2001
GTI-MACE
(Modified Capture ELISA)
HLA typing kits used for detection of IgG antibodies to platelet glycoproteins and HLA Class I antigens Genetic Testing Institute
150 N. Patrick Blvd
Brookfield, WI 53045
BK000031 1/29/2001
Harvest PRP Separation System Blood Bank supplies used for safe and rapid preparation of platelet-rich-plasma (PRP) from a small sample of blood at the patient's point of care Harvest Technologies
77 Accord Park Drive, D7
Norwell, MA 02061
BK000037 2/5/2001
ABS2000
(ver. 1.00.30A SR-1)
Automated blood grouping and antibody test systems used for blood grouping, antibody screening and crossmatch Immucor, Inc
3130 Gateway Drive
Norcross, GA 30091-5625
BK010002 2/16/2001
FluoroTrol
Control Kits
Test for residual white blood cells in leukoreduced blood components BioErgonomics, Inc
4280 Centerville Road
St. Paul, MN 55127
BK000046 4/2/2001
HemoCue
Low Hemoglobin Analyzing System
Automated hemoglobin system used to determine low levels of hemoglobin in plasma, serum, aqueous solutions, or stored or banked blood using a specially designed photometer, the HemoCue Low Hemoglobin Photometer, and specially designed microcuvettes, HemoCue Low Hemoglobin Microcuvettes HemoCue, Inc
9229 Cranford Drive
Potomac, MD 20854
BK000043 4/9/2001
Haemonetics LN8332F Automated blood cell separator used to collect, leukocyte reduce (by gravity filtration), and store two units of apheresis red blood cells for up to 42 days Haemonetics Corp
400 Wood Road
Braintree, MA 02184
BK000048 4/9/2001
SoftBank II
Vers. 21.2
Blood bank transfusion service software which includes electronic crossmatch capability Soft Computer Consultants, Inc
34350 US Highway 19N
Palm Harbor, FL 34684
BK000040 4/20/2001
Model 215 Automated Glycerolization and Deglycerolization System To glycerolize and deglycerolize red blood cell products in a closed system to allow for the extended storage of the deglycerolized red blood cell product for 14 days at 4 degrees centigrade Haemonetics Corp
400 Wood Road
Braintree, MA 02184
BK000002 5/4/2001
Cambridge Biotech HIV-1 Urine Western Blot In vitro qualitative assay for detection and identification of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) Calypte Biomedical Corp
1265 Harbor Bay Parkway
Alameda, CA 94502
BP010009 6/21/2001
ABS2000, Version 2 Software (2.05.00A and 2.05.00B) Automated blood test systems to perform ABO and D blood grouping, antibody detection and Immediate Spin and IgG crossmatch Immucor Inc
3130 Gateway Drive
Norcross, GA 30091-5625
BK000024 7/3/2001
System Blood Bank (SBB) Ver. 3.0 Blood establishment computer software Psyche Systems Corp
Ten Laurel Avenue
Wellesley, MA 02481
BK010017 9/4/2001
IDM Surround System Ver. 3.0 Blood establishment computer software Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018
BK010028 9/5/2001
National Donor Deferral Registry (NDDR) Ver. 1.0 Blood establishment computer software American Blood Resources Association
147 Old Solomons Island Road
Annapolis, MD 21401
BK010012 9/6/2001
ABS2000
Ver. 1.00.30A SR-2
Ver. 2.05.00A
Ver. 2.05.00B
Blood establishment computer software Immucor, Inc
3130 Gateway Drive
Norcross, GA 30091-5625
BK010020 9/24/2001
TRUEGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System Visible Genetics, Inc
700 BAY Street, Suite 1000
Toronto, Ontario
BK000038 9/26/2001
Imugard III-PL Blood transfusion microfilters used for preparation of leukocyte-poor platelets Terumo Medical Corp
125 Blue Ball Road
Elkton, MD 21921
BK000045 9/28/2001
Chiron Procleix
HIV/HCV Proficiency Panel
Quality control kits used for blood borne pathogen testing of donors Gen-Probe
10210 Genetic Center Drive
San Diego, CA 92121-4362
BK010005 10/01/2001
Quik-ID Class II Qualitative HLA test for the detection of panel reactive HLA Class II IgG antibodies (PRA) Genetic Testing Institute
150 N. Patrick Blvd
Brookfield, WI 53045
BK010010 10/01/2001
MTS Incubator II Blood bank incubated ID-MTS Gel Cards and microtest plates used for routine blood bank testing procedures Micro Typing Systems Inc
1295 S.W. 29th Ave
Pompano Beach, FL 33069
BK010021 10/01/2001
Olympus PK 7200 Automated Microplate System Automated blood grouping and antibody test system used to screen for antibodies to Treponema pallidum and CMV Olympus America Inc
Diagnostic Systems Division
3131 West Royal Lane
Irvington, TX 75063-3104
BK010040 10/25/2001
NucliSens HIV-1 QT For use in conjunction with clinical presentation and other laboratory markers of disease progression for prognostic assessment of HIV-1 infected patients, and for monitoring the effects of anti-retroviral therapy by serial measurements of plasma HIV-1 RNA for pediatric and adult patients with baseline viral loads greater than 93,000 and 28,000 copies of HIV-1 viral RNA/mL respectively BioMerieux, Inc
100 Rodolphe Street
Durham, NC 27712
BP010001 11/19/2001
Configurable Laboratory Result Manager (CLRM) Ver. 1.0E Blood Establishment Computer Software Rubin & Poor, Inc
155 Maplewood Avenue, #5
Maplewood, NJ 07040
BK000030 11/23/2001
Chiron CPT Pooling Software, Vers. 2.0.0.2 Blood Establishment Computer Software Chiron Corp
4560 Horton Street
Emeryville, CA 94608-2916
BK000049 12/4/2001
Apheresis Data Integration System (ADIS) Blood Establishment Computer Software Baxter Healthcare Corp
Route 120 and Wilson Road
Round Lake, IL 60073
BK010016 12/4/2001
Transwaag KL Blood device that continuously weighs and mixes blood with the anticoagulant solution in the blood donation bag during the collection process Sarstedt, Inc
P.O. Box 468
Newton, NC 28658-0468
BK010042 12/12/2001
Accurun 1 Multimarker Negative Control Quality control kits for blood banking reagents used as an independent, external run control with in vitro test for HIV, HTLV, HBcAg, antibodies to HCV, antibodies to CMV, antibodies to syphilis, HBsAg, and HIV-1 antigen Boston Biomedica, Inc
375 West Street
West Bridgewater, MA 02379
BK010038 12/18/2001
Sahara Blood and Plasma Warming Device Blood and plasma warming device used to thaw or warm blood products for infusion/transfusion filled in plastic bags Sarstedt, Inc
P.O. Box 468
Newton, NC 28658-0468
BK010045 12/21/2001