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U.S. Department of Health and Human Services

Medical Devices

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Enclosure 2 to Appendix L of In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions

  1. Is there a legally marketed predicate device?

    YES   _____

    NO    _____

     

  2. Does the new device have the same intended use or indications for use of the predicate device?

    YES   _____

    NO    _____

     

  3. If the answer to question #2 is NO, do differences in intended use or indications for use between the new device and the predicate alter the intended therapeutic/diagnostic effect of the new device (consider impact on safety and effectiveness)?

    YES   _____

    NO    _____

     

  4. If the new device has the same intended use or indications for use as the predicate device, or if it does not, and if the differences do not alter the intended therapeutic/diagnostic effect,

     

    • Is it a new analyte?     YES   _____     NO   _____

       

    • Does it utilize novel matrix?     YES   _____     NO   _____

       

    • Does it utilize novel methodology?     YES   _____     NO   _____

       

    • Does it utilize novel technology?     YES   _____     NO   _____

     

  5. If the answer to one of the elements of question #4 is YES, could the change raise new issues of safety and effectiveness?

    YES   _____

    NO    _____

     

  6. If the answer to all elements of question #4 is NO, is the device intended to be used in:

     

    • Traditional Clinical laboratories?     YES   _____     NO   _____

       

    • Point of Care?     YES   _____     NO   _____

       

    • Physician Office Laboratory?     YES   _____     NO   _____

       

    • Over-the-counter?     YES   _____     NO   _____

     

  7. If the device is intended for over-the-counter-use, is the use of the test results well established in lay hands?

    YES   _____

    NO    _____

     

  8. If the device is intended for commercial clinical laboratories, does FDA have knowledge/experience with similar devices?

    YES   _____

    NO    _____

     

  9. If the FDA has knowledge/experience with similar devices, is the use of the device in clinical practice the major determinant in diagnosis or treatment?

    YES   _____

    NO    _____

 

* * * * * * * * * * * * * * * * * *

RATIONALE FOR THE DCLD DECISION CHART

The decision chart is based on an assessment of risk to the patient associated with the use of the device. If the risk of device use is low and predictable, a low level of premarket review may be required for clearance. If the risk is high or unknown, more data is required and a more intense review of the data is necessary.

The first four criteria in the decision chart deal with WHAT is the device, i.e., what it measures, what matrix it uses, what methodology it utilizes, and what technology it employs, and with WHY is the device indicated for use in the clinical setting. If we do not have a clear understanding of what is the device, its clinical relevance and its role in clinical practice, the risk to the patient associated with the use of the device is unknown.

Next, the DCLD decision chart deals with WHO will use the device. The risk to the patient associated with the use of the device will be directly related to the amount of clinical laboratory training and experience of the person performing the test. As user training and experience increases, device risk tends to become lower and more predictable allowing for a lower level of premarket review. Special attention is needed for products intended for use in lay hands; in these settings premarket review may require evaluation of both technical use of the product and use and interpretation of the information generated from over-the -counter testing.

The repeated exposure of FDA reviewers to a specific type of device will lead to a better understanding of the risks to the patient associated with the use of the device. The better understanding of risks will result from the larger number of known studies available with a particular device and from the higher probability of learning about possible device failures through the medical device adverse event reporting program.

Finally, of importance is HOW will the device be used in clinical practice. This question takes into account the importance of the results of the test in patient management. IVD devices that are a major determinant of diagnosis, treatment, or prognosis are associated with high risk to the patient from using the device and require a more stringent level of data review.

Several workshop panelists commented that this item should be placed earlier on in the decision chart. In reality, what impacts on the tier decision is not where in the chart this element is placed, but how major determinant is defiend. If major determinant is defined as the test that is the major determinant or the sole determinant of diagnosis more IVD products will be placed in tier 1 review. If we define major determinant as proposed, i.e., a major deteminant in diagnosis, therapy, or prognosis, then fewer IVD products will receive tier 1 review.

 

* * * * * * * * * * * * * * * * * *

IVD DEVICES SUBJECT TO TIER 1 REVIEW

 

Panel   Product Code   Common Name   Class   Regulation    
                     
IM   DCF   ALBUMIN, ANTIGEN, ANTISERUM, CONTROL   II   866.5040    
                     
IM   JZJ   PREALBUMIN, ANTIGEN, ANTISERUM, CONTROL   I   866.5060    
                     
IM   DDE   CARBONIC ANHYDRASE C, ANTIGEN, ANTISERUM, CONTROL   I   866.5200    
                     
IM   DDH   CARBONIC ANHYDRASE B, ANTIGEN, ANTISERUM, CONTROL   I   866.5200    
                     
IM   KTK   REAGENT, IMMUNOASSAY, CARBONIC ANHYDRASE B AND C   I   866.5200    
                     
IM   DCK   C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL   II   866.5270    
                     
IM   JZH   FACTOR B, ANTIGEN, ANTISERUM, CONTROL   II   866.5320    
                     
IM   DBF   FERRITIN, ANTIGEN, ANTISERUM, CONTROL   II   866.5340    
                     
IM   DCO   ALPHA-GLOBULIN, ANTIGEN, ANTISERUM, CONTROL   I   866.5400    
                     
IM   DAW   ALPHA-2-AP-GLYCOPROTEIN, ANTIGEN, ANTISERUM, CONTROL   I   866.5425    
                     
IM   DBC   ALPHA 2, 2N-GLYCOPROTEIN, ANTIGEN, ANTISERUM, CONTROL   I   866.5425    
                     
IM   DEF   ALPHA-2-HS-GLYCOPROTEIN, ANTIGEN, ANTISERUM, CONTROL   I   866.5425  
                     
IM   DEJ   ALPHA-2-GLYCOPROTEINS, ANTIGEN, ANTISERUM, CONTROL   I   866.5425    
                     
IM   DDN   BETA-2-GLYCOPROTEIN I, ANTIGEN, ANTISERUM, CONTROL   I   866.5430    
                     
IM   DDK   BETA-2-GLYCOPROTEIN III, ANTIGEN, ANTISERUM, CONTROL   I   866.5440    
                     
IM   DAD   HAPTOGLOBIN, ANTIGEN, ANTISERUM, CONTROL   II   866.5460    
                     
IM   DDG   TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL   II   866.5880    
                     
IM   CZO   INTER-ALPHA TRYPSIN INHIBITOR, ANTIGEN, ANTISERUM, CONTROL   I   866.5890    
                     
CH   CIX   BROMCRESOL GREEN DYE­BINDING, ALBUMIN   II   862.1035    
                     
CH   CJW   BROMCRESOL PURPLE DYE­BINDING, ALBUMIN   II   862.1035    
                     
CH   CJZ   ACID, HYDROXYAZOBENZENE­BENZOIC, ALBUMIN   II   862.1035    
                     
CH   CJF   TETRABROMOPHENOLPHTHALEIN, ALBUMIN   II   862.1035    
                     
CH   CJQ   RADIAL IMMUNODIFFUSION, ALBUMIN   II   862.1035    
                     
CH   CJG   TETRABROMO­M­CRESOLSULFONPHTHALEIN, ALBUMIN   II   862.1035    
                     
CH   CJC   FRUCTOSE­1, 6­DIPHOSPHATE AND NADH (U.V.), ALDOLASE   I   862.1040    
                     
CH   CJT   HYDRAZONE COLORIMETRY, ALDOLASE   I   862.1040    
                     
CH   JKL   ACID, DELTA­AMINOLEVULINIC, ION­EXCHANGE COLUMNS WITH COLORIMETRY   I   862.1060    
                     
CH   JID   PHOTOMETRIC METHOD, AMMONIA   I   862.1065    
                     
CH   JIF   ENZYMATIC METHOD, AMMONIA   I   862.1065    
                     
CH   JIG   ELECTRODE, ION­SPECIFIC METHOD, AMMONIA   I   862.1065    
                     
CH   JIE   METHOD, ION­EXCHANGE, AMMONIA   I   862.1065    
                     
CH   CIZ   RADIOIMMUNOASSAY, ANDROSTENEDIONE   I   862.1075    
                     
CH   CIY   RADIOIMMUNOASSAY, ANDROSTERONE   I   862.1080    
                     
CH   JMA   ACID, ASCORBIC, 2,4­DINITROPHENYLHYDRAZINE (SPECTROPHOTOMETRIC)   I   862.1095    
                     
CH   CIS   HYDRAZONE COLORIMETRY, AST/SGOT   II   862.1100    
                     
CH   CIT   NADH OXIDATION/NAD REDUCTION, AST/SGOT   II   862.1100    
                     
CH   CIQ   DIAZO, AST/SGOT   II   862.1100    
                     
CH   CIF   VANILLIN PYRUVATE, AST/SGOT   II   862.1100    
                     
CH   JJB   AZO­DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON­QUANT.)   I   862.1115    
                     
CH   JKW   N­ACETYL­L­TYROSINE ETHYL ESTER (U.V.), CHYMOTRYPSIN   I   862.1180    
                     
CH   JKX   N­BENZOYL­L­TYROSINE ETHYL ESTER (U.V.), CHYMOTRYPSIN   I   862.1180  
                     
CH   CHE   RADIOIMMUNOASSAY, CORTICOIDS   I   862.1195    
                     
CH   JKC   RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)   I   862.1245    
                     
CH   CGN   ACID, FOLIC, RADIOIMMUNOASSAY   II   862.1295    
                     
CH   JGE   TURBIDIMETRIC METHOD, GLOBULIN   I   862.1330    
                     
CH   JGD   NEPHELOMETRIC METHOD, GLOBULIN   I   862.1330    
                     
CH   JGC   TRYPTOPHAN MEASUREMENT (COLORIMETRIC), GLOBULIN   I   862.1330    
                     
CH   CGH   ELECTROPHORETIC, GLOBULIN   I   862.1330    
                     
CH   JPZ   COLORIMETRIC METHOD, GAMMA­GLUTAMYL TRANSPEPTIDASE   I   862.1360    
                     
CH   JQA   ELECTROPHORETIC, GAMMA­GLUTAMYL TRANSPEPTIDASE ISOENZYMES   I   862.1360    
                     
CH   JQB   KINETIC METHOD, GAMMA­GLUTAMYL TRANSPEPTIDASE   I   862.1360    
                     
CH   CCZ   ZIMMERMAN/NORYMBERSKI, 17­KETOGENIC STEROIDS   I   862.1385    
                     
CH   JHE   RADIOASSAY, 17­HYDROXYCORTICOSTEROIDS   I   862.1385    
                     
CH   CDB   PORTER SILBER HYDRAZONE, 17­HYDROXYCORTICOSTEROIDS   I   862.1385    
                     
CH   JHD   FLUOROMETRIC METHOD, 17­HYDROXYCORTICOSTEROIDS   I   862.1385    
                     
CH   JIZ   ATOMIC ABSORPTION, IRON (NON­HEME)   I   862.1410    
                     
CH   JJA   RADIO­LABELED IRON METHOD, IRON (NON­HEME)   I   862.1410    
                     
CH   JIY   PHOTOMETRIC METHOD, IRON (NON­HEME)   I   862.1410    
                     
CH   CFM   BATHOPHENANTHROLINE, COLORIMETRY, IRON (NON­HEME)   I   862.1410    
                     
CH   JQF   BATHOPHENANTHROLINE, IRON BINDING CAPACITY   I   862.1415    
                     
CH   JMO   FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY   I   862.1415    
                     
CH   JQD   RESIN, ION­EXCHANGE, THIOGLYCOLIC ACID, COLORIMETRY, IRON BINDING CAPACITY   I   862.1415    
                     
CH   JQE   RESIN, ION­EXCHANGE, ASCORBIC ACID, COLORIMETRY, IRON BINDING CAPACITY   I   862.1415    
                     
CH   JQG   RADIOMETRIC, FE59, IRON BINDING CAPACITY   I   862.1415    
                     
CH   CCY   ZIMMERMAN (SPECTROPHOTOMETRIC), 17­KETOSTEROIDS   I   862.1430    
                     
CH   CFH   TETRAZOLIUM INT DYE­DIAPHORASE, LACTATE DEHYDROGENASE   II   862.1440    
                     
CH   CER   2,4­DINITROPHENYLHYDRAZINE, LACTATE DEHYDROGENASE   II   862.1440    
                     
CH   CFJ   NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE   II   862.1440    
                     
CH   JGG   L­LEUCINE­4­NITROANILIDE (COLORIMETRIC), LEUCINE ARYLAMIDASE   I   862.1460    
                     
CH   CDC   L­LEUCYL B­NAPHTHYLAMIDE, LEUCINE AMINOPEPTIDASE   I   862.1460    
                     
CH   JMS   ACID, OXALACETIC AND NADH OXIDATION (U.V.), MALIC DEHYDROGENASE   I   862.1500    
                     
CH   JQN   COLORIMETRIC, MUCOPOLYSACCHARIDES   I   862.1505    
                     
CH   LPW   SYSTEM, TEST, OXALATE   I   862.1542    
                     
CH   CEO   PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS   I   862.1580    
                     
CH   JGR   REFRACTOMETRIC, TOTAL PROTEIN   II   862.1635    
                     
CH   JGQ   TURBIDIMETRIC, TOTAL PROTEIN   II   862.1635    
                     
CH   JGP   LOWRY (COLORIMETRIC), TOTAL PROTEIN   II   862.1635    
                     
CH   CEK   BIURET (COLORIMETRIC), TOTAL PROTEIN   II   862.1635    
                     
CH   JIR   INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON­QUANT.)   I   862.1645    
                     
CH   JIQ   TURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON­QUANT.)   I   862.1645    
                     
CH   JJS   CONTROLS FOR BLOOD­GASES, (ASSAYED AND UNASSAYED)   I   862.1660    
                     
CH   JJW   URINALYSIS CONTROLS (ASSAYED AND UNASSAYED)   I   862.1660    
                     
CH   JJT   ENZYME CONTROLS (ASSAYED AND UNASSAYED)   I   862.1660    
                     
CH   JJX   SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)   I   862.1660    
                     
CH   JJR   ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)   I   862.1660    
                     
CH   JJY   MULTI­ANALYTE CONTROLS, ALL KINDS (ASSAYED AND UNASSAYED)   I   862.1660    
                     
CH   JNO   N­BENZOYL­L­ARGININE ETHYL ESTER (U.V.), TRYPSIN   I   862.1725    
                     
CH   JNN   P­TOLUENESULPHONYL­L­ARGININE METHYL ESTER (U.V.), TRYPSIN   I   862.1725    
                     
CH   JNP   INFRARED SPECTROSCOPY MEASUREMENT, URINARY CALCULI (STONE)   I   862.1780    
                     
CH   JNQ   QUALITATIVE CHEMICAL REACTIONS, URINARY CALCULI (STONE)   I   862.1780    
                     
TX   DKO   ADSORBENTS, ION­EXCHANGE   I   862.2230    
                     
TX   DMG   PAPERS, ION   I   862.2230    
                     
TX   KEA   RESINS, ION­EXCHANGE   I   862.2230    
                     
TX   DMS   GASES, GLC   I   862.2250    
                     
TX   DJA   COLUMN SUPPORTS, GLC   I   862.2250    
                     
TX   DLG   COATING, LIQUID, GLC   I   862.2250    
                     
TX   LEQ   DETECTORS, ELECTROCHEMICAL, LIQUID CHROMATOGRAPHY   I   862.2260    
                     
TX   DMZ   LIQUID CHROMATOGRAPHY, ADSORBENT   I   862.2260    
                     
TX   DNH   RESINS, ION­EXCHANGE, LIQUID CHROMATOGRAPHY   I   862.2260    
                     
TX   DPA   APPARATUS, GENERAL USE, THIN LAYER CHROMATOGRAPHY   I   862.2270    
                     
TX   DLY   PLATE, ALUMINA, TLC   I   862.2270    
                     
TX   DLC   ATOMIZER, TLC   I   862.2270    
                     
TX   DLO   INDICATOR, SILICA GEL FLUORESCENT, TLC   I   862.2270    
                     
TX   DJO   INDICATOR, CELLULOSE FLUORESCENT, TLC   I   862.2270    
                     
TX   DJS   U.V. LIGHT, TLC   I   862.2270    
                     
TX   DKG   PLATE, CELLULOSE, TLC   I   862.2270    
                     
TX   DKK   TANKS, DEVELOPING, TLC   I   862.2270    
                     
TX   DKS   PLATE, SILICA GEL, TLC   I   862.2270    
                     
TX   DKY   INDICATOR, ALUMINA FLUORESCENT, TLC   I   862.2270    
                     
TX   DIF   DRUG MIXTURE CONTROL MATERIALS   I   862.3280    
                     
TX   DIE   HEAVY METALS CONTROL MATERIALS   I   862.3280    
                     
TX   LAX   LIDOCAINE CONTROL MATERIALS   I   862.3280    
                     
TX   LAW   THEOPHYLLINE CONTROL MATERIALS   I   862.3280    
                     
TX   LAZ   N­ACETYLPROCAINAMIDE CONTROL MATERIALS   I   862.3280    
                     
TX   LAY   METHOTREXATE CONTROL MATERIALS   I   862.3280    
                     
TX   LAS   DRUG SPECIFIC CONTROL MATERIALS   I   862.3280    
                     
TX   DMP   DIGOXIN CONTROL SERUM, RIA   I   862.3280    
                     
TX   DKC   ALCOHOL CONTROL MATERIALS   I   862.3280    
                     
TX   DJK   DIGITOXIN CONTROL SERUM, RIA   I   862.3280    
                     
TX   LBA   PROCAINAMIDE CONTROL MATERIALS   I   862.3280    
                     
HE   GHK   CENTRIFUGE, MICROSEDIMENTATION   I   864.5350    
                     
HE   GIO   TUBE, COLLECTION, CAPILLARY BLOOD   I   864.6150    
                     
HE   JIO   BLOOD, OCCULT, COLORIMETRIC, IN URINE   II   864.6550    
                     
HE   JIP   BLOOD, OCCULT, ENZYMATIC METHOD, IN URINE   II   864.6550    
                     
MI   JTY   CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA   II   866.2410    
                     
MI   JSP   KIT, ANAEROBIC IDENTIFICATION   I   866.2660    
                     
MI   JSR   KIT, IDENTIFICATION, DERMATOPHYTE   I   866.2660    
                     
MI   JSS   KIT, IDENTIFICATION, ENTEROBACTERIACEAE   I   866.2660    
                     
MI   JSW   KIT, IDENTIFICATION, GLUCOSE NONFERMENTER   I   866.2660    
                     
MI   JSZ   KIT, IDENTIFICATION, PSEUDOMONAS   I   866.2660    
                     
MI   JTO   DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION   I   866.2660    
                     
MI   LIB   DEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC   I   866.2660    
                     
MI   LJG   QUALITY CONTROL SLIDES   I   866.2660    
                     
MI   LQL   GRAM POSITIVE IDENTIFICATION PANEL   I   866.2660    
                     
MI   LQM   GRAM NEGATIVE IDENTIFICATION PANEL   I   866.2660    
                     
MI   LKS   DEVICE, PARASITE CONCENTRATION   I   866.2900    
                     
MI   JWT   ANTIGEN, CF, ASPERGILLUS SPP.   I   866.3040    
                     
MI   GSN   ANTISERUM, POSITIVE AND NEGATIVE FEBRILE ANTIGEN CONTROL SERUM   II   866.3085    
                     
MI   GSO   ANTIGENS (FEBRILE), AGGLUTINATION, BRUCELLA SPP.   II   866.3085    
                     
MI   GMG   ANTIGEN, LATEX AGGLUTINATION, COCCIDIOIDES IMMITIS   II   866.3135    
                     
MI   GMI   ANTIGEN, CF AND/OR ID, COCCIDIOIDES IMMITIS   II   866.3135    
                     
MI   GOP   ANTISERA, C. ACNES (553, 605)   I   866.3140    
                     
MI   KLH   ANTISERA, C. ACNES   I   866.3140    
                     
MI   GNG   ANTIGENS, CF (INCLUDING CF CONTROL), COXSACKIEVIRUS A 1­24, B 1­6   I   866.3145  
                     
MI   GNN   ANTISERA, NEUTRALIZATION, COXSACKIEVIRUS A 1­24, B 1­6   I   866.3145    
                     
MI   GNO   ANTISERA, CF, COXSACKIEVIRUS A 1­24, B 1­6   I   866.3145    
                     
MI   GQH   ANTIGEN, CF (INCLUDING CF CONTROL), CYTOMEGALOVIRUS   II   866.3175    
                     
MI   GQI   ANTISERUM, CF, CYTOMEGALOVIRUS   II   866.3175    
                     
MI   LJO   ANTIGEN, IHA, CYTOMEGALOVIRUS   II   866.3175    
                     
MI   GNQ   ANTIGEN, CF (INCLUDING CF CONTROL), EPSTEIN­BARR VIRUS   I   866.3235    
                     
MI   GQC   ANTISERA, CF, EQUINE ENCEPHALITIS VIRUS, EEE, WEE   I   866.3240    
                     
MI   GQD   ANTIGENS, CF (INCLUDING CF CONTROL), EQUINE ENCEPHALITIS VIRUS, EEE, WEE   I   866.3240    
                     
MI   GQN   ANTIGEN, CF (INCLUDING CF CONTROL), HERPESVIRUS HOMINIS 1,2   III   866.3305    
                     
MI   GQO   ANTISERA, CF, HERPESVIRUS HOMINIS 1,2   III   866.3305    
                     
MI   LKC   ANTIGENS, INDIRECT HEMAGGLUTINATION (IHA) HERPES SIMPLEX VIRUS   III   866.3305    
                     
MI   GQJ   ANTISERUM, CF, LYMPHOCYTIC CHORIOMENINGITIS VIRUS   I   866.3360    
                     
MI   GQK   ANTIGEN, CF, LYMPHOCYTIC CHORIOMENINGITIS VIRUS   I   866.3360    
                     
MI   GSB   ANTIGENS, CF, ALL, MYCOPLASMA SPP.   I   866.3375    
                     
MI   GQY   ANTIGEN, HA (INCLUDING HA CONTROL), MUMPS VIRUS   I   866.3380    
                     
MI   GQZ   ANTISERUM, NEUTRALIZATION, MUMPS VIRUS   I   866.3380    
                     
MI   GRB   ANTISERUM, CF, MUMPS VIRUS   I   866.3380    
                     
MI   GRC   ANTIGEN, CF (INCLUDING CF CONTROL), MUMPS VIRUS   I   866.3380    
                     
MI   GRD   ANTISERUM, HAI, MUMPS VIRUS   I   866.3380    
                     
MI   GOG   ANTISERA, CF, POLIOVIRUS 1­3   I   866.3405    
                     
MI   GOH   ANTIGENS, CF (INCLUDING CF CONTROL), POLIOVIRUS 1­3   I   866.3405    
                     
MI   GQG   ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS   I   866.3480    
                     
MI   GPO   ANTIGEN, CF, TYPHUS FEVER GROUP   I   866.3500    
                     
MI   GPQ   ANTIGEN, CF, SPOTTED FEVER GROUP   I   866.3500    
                     
MI   GPR   ANTISERUM, CF, Q FEVER   I   866.3500    
                     
MI   GPS   ANTIGEN, CF, Q FEVER   I   866.3500    
                     
MI   GOK   ANTISERA, HAI (INCLUDING HAI CONTROL), RUBELLA   III   866.3510    
                     
MI   GOL   ANTIGEN, HA (INCLUDING HA CONTROL), RUBELLA   III   866.3510    
                     
MI   GOM   ANTISERA, CF, RUBELLA   III   866.3510    
                     
MI   GON   ANTIGEN, CF (INCLUDING CF CONTROL), RUBELLA   III   866.3510    
                     
MI   GNC   ANTIGENS, FEBRILE, SLIDE AND TUBE, ALL GROUPS, SLAMONELLA SPP.   II   866.3550    
                     
MI   GOO   ANTISERA, FLUORESCENT, ALL GLOBULINS, SALMONELLA SPP.   II   866.3550    
                     
MI   GRL   ANTIGENS, ALL GROUPS, SALMONELLA SPP.   II   866.3550    
                     
MI   GRM   ANTISERA, ALL GROUPS, SALMONELLA SPP.   II   866.3550    
                     
MI   GLZ   ANTIGENS, IF, TOXOPLASMA GONDII   II   866.3780    
                     
MI   GMM   ANTIGENS, IHA, TOXOPLASMA GONDII   II   866.3780    
                     
MI   GMN   ANTIGENS, CF, TOXOPLASMA GONDII   II   866.3780    
                     
MI   GND   ANTIGEN, IHA, T. CRUZI   I   866.3870    
                     
MI   GNF   ANTIGEN, CF, T. CRUZI   I   866.3870    
                     
MI   GQW   ANTIGEN, CF, (INCLUDING CF CONTROL), VARICELLA­ZOSTER   II   866.3900    
                     
MI   GQX   ANTISERUM, CF, VARICELLA­ZOSTER   II   866.3900