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Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
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 | 866.1 | Scope. |
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| 866.3 | Effective dates of requirement for premarket approval. |
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| 866.9 | Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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| 866.1620 | Antimicrobial susceptibility test disc. |
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| 866.1640 | Antimicrobial susceptibility test powder. |
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| 866.1700 | Culture medium for antimicrobial susceptibility tests. |
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| 866.2050 | Staphylococcal typing bacteriophage. |
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| 866.2120 | Anaerobic chamber. |
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| 866.2160 | Coagulase plasma. |
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| 866.2170 | Automated colony counter. |
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| 866.2180 | Manual colony counter. |
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| 866.2300 | Multipurpose culture medium. |
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| 866.2320 | Differential culture medium. |
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| 866.2330 | Enriched culture medium. |
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| 866.2350 | Microbiological assay culture medium. |
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| 866.2360 | Selective culture medium. |
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| 866.2390 | Transport culture medium. |
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| 866.2410 | Culture medium for pathogenic Neisseria spp. |
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| 866.2420 | Oxidase screening test for gonorrhea. |
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| 866.2440 | Automated medium dispensing and stacking device. |
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| 866.2450 | Supplement for culture media. |
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| 866.2480 | Quality control kit for culture media. |
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| 866.2500 | Microtiter diluting and dispensing device. |
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| 866.2540 | Microbiological incubator. |
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| 866.2560 | Microbial growth monitor. |
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| 866.2580 | Gas-generating device. |
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| 866.2600 | Wood's fluorescent lamp. |
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| 866.2660 | Microorganism differentiation and identification device. |
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| 866.2850 | Automated zone reader. |
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| 866.2900 | Microbiological specimen collection and transport device. |
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| 866.3010 | Acinetobacter calcoaceticus serological reagents. |
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| 866.3020 | Adenovirus serological reagents. |
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| 866.3035 | Arizona spp. serological reagents. |
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| 866.3040 | Aspergillus spp. serological reagents. |
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| 866.3060 | Blastomyces dermatitidis serological reagents. |
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| 866.3065 | Bordetella spp. serological reagents. |
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| 866.3085 | Brucella spp. serological reagents. |
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| 866.3110 | Campylobacter fetus serological reagents. |
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| 866.3120 | Chlamydia serological reagents. |
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| 866.3125 | Citrobacter spp. serological reagents. |
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| 866.3135 | Coccidioides immitis serological reagents. |
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| 866.3140 | Corynebacterium spp. serological reagents. |
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| 866.3145 | Coxsackievirus serological reagents. |
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| 866.3165 | Cryptococcus neoformans serological reagents. |
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| 866.3175 | Cytomegalovirus serological reagents. |
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| 866.3200 | Echinococcus spp. serological reagents. |
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| 866.3205 | Echovirus serological reagents. |
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| 866.3220 | Entamoeba histolytica serological reagents. |
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| 866.3235 | Epstein-Barr virus serological reagents. |
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| 866.3240 | Equine encephalomyelitis virus serological reagents. |
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| 866.3250 | Erysipelothrix rhusiopathiae serological reagents. |
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| 866.3255 | Escherichia coli serological reagents. |
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| 866.3270 | Flavobacterium spp. serological reagents. |
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| 866.3280 | Francisella tularensis serological reagents. |
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| 866.3290 | Gonococcal antibody test (GAT). |
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| 866.3300 | Haemophilus spp. serological reagents. |
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| 866.3305 | Herpes simplex virus serological reagents. |
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| 866.3320 | Histoplasma capsulatum serological reagents. |
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| 866.3330 | Influenza virus serological reagents. |
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| 866.3340 | Klebsiella spp. serological reagents. |
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| 866.3350 | Leptospira spp. serological reagents. |
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| 866.3355 | Listeria spp. serological reagents. |
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| 866.3360 | Lymphocytic choriomeningitis virus serological reagents. |
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| 866.3370 | Mycobacterium tuberculosis immunofluorescent reagents. |
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| 866.3375 | Mycoplasma spp. serological reagents. |
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| 866.3380 | Mumps virus serological reagents. |
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| 866.3390 | Neisseria spp. direct serological test reagents. |
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| 866.3400 | Parainfluenza virus serological reagents. |
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| 866.3405 | Poliovirus serological reagents. |
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| 866.3410 | Proteus spp. (Weil-Felix) serological reagents. |
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| 866.3415 | Pseudomonas spp. serological reagents. |
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| 866.3460 | Rabiesvirus immunofluorescent reagents. |
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| 866.3470 | Reovirus serological reagents. |
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| 866.3480 | Respiratory syncytial virus serological reagents. |
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| 866.3490 | Rhinovirus serological reagents. |
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| 866.3500 | Rickettsia serological reagents. |
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| 866.3510 | Rubella virus serological reagents. |
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| 866.3510 | Rubella virus serological reagents. |
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| 866.3520 | Rubeola (measles) virus serological reagents. |
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| 866.3550 | Salmonella spp. serological reagents. |
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| 866.3600 | Schistosoma spp. serological reagents. |
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| 866.3630 | Serratia spp. serological reagents. |
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| 866.3660 | Shigella spp. serological reagents. |
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| 866.3680 | Sporothrix schenckii serological reagents. |
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| 866.3700 | Staphylococcus aureus serological reagents. |
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| 866.3720 | Streptococcus spp. exoenzyme reagents. |
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| 866.3740 | Streptococcus spp. serological reagents. |
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| 866.3780 | Toxoplasma gondii serological reagents. |
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| 866.3820 | Treponema pallidum nontreponemal test reagents. |
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| 866.3830 | Treponema pallidum treponemal test reagents. |
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| 866.3850 | Trichinella spiralis serological reagents. |
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| 866.3870 | Trypanosoma spp. serological reagents. |
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| 866.3900 | Varicella-zoster virus serological reagents. |
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| 866.3930 | Vibrio cholerae serological reagents. |
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| 866.4100 | Complement reagent. |
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| 866.4500 | Immunoelectrophoresis equipment. |
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| 866.4520 | Immunofluorometer equipment. |
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| 866.4540 | Immunonephelometer equipment. |
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| 866.4600 | Ouchterlony agar plate. |
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| 866.4800 | Radial immunodiffusion plate. |
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| 866.4830 | Rocket immunoelectrophoresis equipment. |
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| 866.4900 | Support gel. |
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| 866.5040 | Albumin immunological test system. |
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| 866.5060 | Prealbumin immunological test system. |
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| 866.5065 | Human allotypic marker immunological test system. |
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| 866.5080 | Alpha-1-antichymotrypsin immunological test system. |
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| 866.5090 | Antimitochondrial antibody immunological test system. |
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| 866.5100 | Antinuclear antibody immunological test system. |
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| 866.5110 | Antiparietal antibody immunological test system. |
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| 866.5120 | Antismooth muscle antibody immunological test system. |
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| 866.5130 | Alpha-1-antitrypsin immunological test system. |
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| 866.5150 | Bence-Jones proteins immunological test system. |
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| 866.5160 | Beta-globulin immunological test system. |
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| 866.5170 | Breast milk immunological test system. |
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| 866.5200 | Carbonic anhydrase B and C immunological test system. |
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| 866.5210 | Ceruloplasmin immunological test system. |
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| 866.5220 | Cohn fraction II immunological test system. |
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| 866.5230 | Colostrum immunological test system. |
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| 866.5240 | Complement components immunological test system. |
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| 866.5250 | Complement C1 inhibitor (inactivator) immunological test system. |
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| 866.5260 | Complement C3b inactivator immunological test system. |
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| 866.5270 | C-reactive protein immunological test system. |
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| 866.5320 | Properdin factor B immunological test system. |
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| 866.5330 | Factor XIII, A, S, immunological test system. |
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| 866.5340 | Ferritin immunological test system. |
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| 866.5350 | Fibrinopeptide A immunological test system. |
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| 866.5360 | Cohn fraction IV immunological test system. |
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| 866.5370 | Cohn fraction V immunological test system. |
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| 866.5380 | Free secretory component immunological test system. |
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| 866.5400 | Alpha-globulin immunological test system. |
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| 866.5420 | Alpha-1-glycoproteins immunological test system. |
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| 866.5425 | Alpha-2-glycoproteins immunological test system. |
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| 866.5430 | Beta-2-glycoprotein I immunological test system. |
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| 866.5440 | Beta-2-glycoprotein III immunological test system. |
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| 866.5460 | Haptoglobin immunological test system. |
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| 866.5470 | Hemoglobin immunological test system. |
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| 866.5490 | Hemopexin immunological test system. |
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| 866.5500 | Hypersensitivity pneumonitis immunological test system. |
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| 866.5510 | Immunoglobulins A, G, M, D, and E immunological test system. |
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| 866.5520 | Immunoglobulin G (Fab fragment specific) immunological test system. |
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| 866.5530 | Immunoglobulin G (Fc fragment specific) immunological test system. |
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| 866.5540 | Immunoglobulin G (Fd fragment specific) immunological test system. |
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| 866.5550 | Immunoglobulin (light chain specific) immunological test system. |
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| 866.5560 | Lactic dehydrogenase immunological test system. |
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| 866.5570 | Lactoferrin immunological test system. |
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| 866.5580 | Alpha-1-lipoprotein immunological test system. |
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| 866.5590 | Lipoprotein X immunological test system. |
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| 866.5600 | Low-density lipoprotein immunological test system. |
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| 866.5620 | Alpha-2-macroglobulin immunological test system. |
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| 866.5630 | Beta-2-microglobulin immunological test system. |
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| 866.5640 | Infectious mononucleosis immunological test system. |
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| 866.5660 | Multiple autoantibodies immunological test system. |
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| 866.5680 | Myoglobin immunological test system. |
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| 866.5700 | Whole human plasma or serum immunological test system. |
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| 866.5715 | Plasminogen immunological test system. |
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| 866.5735 | Prothrombin immunological test system. |
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| 866.5750 | Radioallergosorbent (RAST) immunological test system. |
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| 866.5765 | Retinol-binding protein immunological test system. |
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| 866.5775 | Rheumatoid factor immunological test system. |
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| 866.5800 | Seminal fluid (sperm) immunological test system. |
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| 866.5820 | Systemic lupus erythematosus immunological test system. |
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| 866.5860 | Total spinal fluid immunological test system. |
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| 866.5870 | Thyroid autoantibody immunological test system. |
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| 866.5880 | Transferrin immunological test system. |
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| 866.5890 | Inter-alpha trypsin inhibitor immunological test system. |
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| 866.6010 | Tumor-associated antigen immunological test system. |
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