Title 21

PART 866

Part 866 - Immunology And Microbiology Devices

PART 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES Authority:21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. Source:47 FR 50823, Nov. 9, 1982, unless otherwise noted. Editorial Note:Nomenclature changes to part 866 appear at 73 FR 35341, June 23, 2008.

21:8.0.1.1.20.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.20.1.1.1SECTION 866.1
   866.1 Scope.
21:8.0.1.1.20.1.1.2SECTION 866.3
   866.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.20.1.1.3SECTION 866.9
   866.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.20.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.20.2.1.1SECTION 866.1620
   866.1620 Antimicrobial susceptibility test disc.
21:8.0.1.1.20.2.1.2SECTION 866.1640
   866.1640 Antimicrobial susceptibility test powder.
21:8.0.1.1.20.2.1.3SECTION 866.1645
   866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
21:8.0.1.1.20.2.1.4SECTION 866.1700
   866.1700 Culture medium for antimicrobial susceptibility tests.
21:8.0.1.1.20.3SUBPART C
Subpart C - Microbiology Devices
21:8.0.1.1.20.3.1.1SECTION 866.2050
   866.2050 Staphylococcal typing bacteriophage.
21:8.0.1.1.20.3.1.2SECTION 866.2120
   866.2120 Anaerobic chamber.
21:8.0.1.1.20.3.1.3SECTION 866.2160
   866.2160 Coagulase plasma.
21:8.0.1.1.20.3.1.4SECTION 866.2170
   866.2170 Automated colony counter.
21:8.0.1.1.20.3.1.5SECTION 866.2180
   866.2180 Manual colony counter.
21:8.0.1.1.20.3.1.6SECTION 866.2190
   866.2190 Automated image assessment system for microbial colonies on solid culture media.
21:8.0.1.1.20.3.1.7SECTION 866.2300
   866.2300 Multipurpose culture medium.
21:8.0.1.1.20.3.1.8SECTION 866.2320
   866.2320 Differential culture medium.
21:8.0.1.1.20.3.1.9SECTION 866.2330
   866.2330 Enriched culture medium.
21:8.0.1.1.20.3.1.10SECTION 866.2350
   866.2350 Microbiological assay culture medium.
21:8.0.1.1.20.3.1.11SECTION 866.2360
   866.2360 Selective culture medium.
21:8.0.1.1.20.3.1.12SECTION 866.2390
   866.2390 Transport culture medium.
21:8.0.1.1.20.3.1.13SECTION 866.2410
   866.2410 Culture medium for pathogenic Neisseria spp.
21:8.0.1.1.20.3.1.14SECTION 866.2420
   866.2420 Oxidase screening test for gonorrhea.
21:8.0.1.1.20.3.1.15SECTION 866.2440
   866.2440 Automated medium dispensing and stacking device.
21:8.0.1.1.20.3.1.16SECTION 866.2450
   866.2450 Supplement for culture media.
21:8.0.1.1.20.3.1.17SECTION 866.2480
   866.2480 Quality control kit for culture media.
21:8.0.1.1.20.3.1.18SECTION 866.2500
   866.2500 Microtiter diluting and dispensing device.
21:8.0.1.1.20.3.1.19SECTION 866.2540
   866.2540 Microbiological incubator.
21:8.0.1.1.20.3.1.20SECTION 866.2560
   866.2560 Microbial growth monitor.
21:8.0.1.1.20.3.1.21SECTION 866.2580
   866.2580 Gas-generating device.
21:8.0.1.1.20.3.1.22SECTION 866.2600
   866.2600 Wood's fluorescent lamp.
21:8.0.1.1.20.3.1.23SECTION 866.2660
   866.2660 Microorganism differentiation and identification device.
21:8.0.1.1.20.3.1.24SECTION 866.2680
   866.2680 Streptococcus spp. nucleic acid-based assay.
21:8.0.1.1.20.3.1.25SECTION 866.2850
   866.2850 Automated zone reader.
21:8.0.1.1.20.3.1.26SECTION 866.2900
   866.2900 Microbiological specimen collection and transport device.
21:8.0.1.1.20.4SUBPART D
Subpart D - Serological Reagents
21:8.0.1.1.20.4.1.1SECTION 866.3010
   866.3010 Acinetobacter calcoaceticus serological reagents.
21:8.0.1.1.20.4.1.2SECTION 866.3020
   866.3020 Adenovirus serological reagents.
21:8.0.1.1.20.4.1.3SECTION 866.3035
   866.3035 Arizona spp. serological reagents.
21:8.0.1.1.20.4.1.4SECTION 866.3040
   866.3040 Aspergillus spp. serological reagents.
21:8.0.1.1.20.4.1.5SECTION 866.3045
   866.3045 In vitro diagnostic device for Bacillus spp. detection.
21:8.0.1.1.20.4.1.6SECTION 866.3050
   866.3050 Beta-glucan serological assays.
21:8.0.1.1.20.4.1.7SECTION 866.3060
   866.3060 Blastomyces dermatitidis serological reagents.
21:8.0.1.1.20.4.1.8SECTION 866.3065
   866.3065 Bordetella spp. serological reagents.
21:8.0.1.1.20.4.1.9SECTION 866.3085
   866.3085 Brucella spp. serological reagents.
21:8.0.1.1.20.4.1.10SECTION 866.3110
   866.3110 Campylobacter fetus serological reagents.
21:8.0.1.1.20.4.1.11SECTION 866.3120
   866.3120 Chlamydia serological reagents.
21:8.0.1.1.20.4.1.12SECTION 866.3125
   866.3125 Citrobacter spp. serological reagents.
21:8.0.1.1.20.4.1.13SECTION 866.3130
   866.3130 Clostridium difficile toxin gene amplification assay.
21:8.0.1.1.20.4.1.14SECTION 866.3135
   866.3135 Coccidioides immitis serological reagents.
21:8.0.1.1.20.4.1.15SECTION 866.3140
   866.3140 Corynebacterium spp. serological reagents.
21:8.0.1.1.20.4.1.16SECTION 866.3145
   866.3145 Coxsackievirus serological reagents.
21:8.0.1.1.20.4.1.17SECTION 866.3165
   866.3165 Cryptococcus neoformans serological reagents.
21:8.0.1.1.20.4.1.18SECTION 866.3175
   866.3175 Cytomegalovirus serological reagents.
21:8.0.1.1.20.4.1.19SECTION 866.3200
   866.3200 Echinococcus spp. serological reagents.
21:8.0.1.1.20.4.1.20SECTION 866.3205
   866.3205 Echovirus serological reagents.
21:8.0.1.1.20.4.1.21SECTION 866.3210
   866.3210 Endotoxin assay.
21:8.0.1.1.20.4.1.22SECTION 866.3215
   866.3215 Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
21:8.0.1.1.20.4.1.23SECTION 866.3220
   866.3220 Entamoeba histolytica serological reagents.
21:8.0.1.1.20.4.1.24SECTION 866.3225
   866.3225 Enterovirus nucleic acid assay.
21:8.0.1.1.20.4.1.25SECTION 866.3235
   866.3235 Epstein-Barr virus serological reagents.
21:8.0.1.1.20.4.1.26SECTION 866.3240
   866.3240 Equine encephalomyelitis virus serological reagents.
21:8.0.1.1.20.4.1.27SECTION 866.3250
   866.3250 Erysipelothrix rhusiopathiae serological reagents.
21:8.0.1.1.20.4.1.28SECTION 866.3255
   866.3255 Escherichia coli serological reagents.
21:8.0.1.1.20.4.1.29SECTION 866.3270
   866.3270 Flavobacterium spp. serological reagents.
21:8.0.1.1.20.4.1.30SECTION 866.3280
   866.3280 Francisella tularensis serological reagents.
21:8.0.1.1.20.4.1.31SECTION 866.3290
   866.3290 Gonococcal antibody test (GAT).
21:8.0.1.1.20.4.1.32SECTION 866.3300
   866.3300 Haemophilus spp. serological reagents.
21:8.0.1.1.20.4.1.33SECTION 866.3305
   866.3305 Herpes simplex virus serological assays.
21:8.0.1.1.20.4.1.34SECTION 866.3309
   866.3309 Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
21:8.0.1.1.20.4.1.35SECTION 866.3310
   866.3310 Hepatitis A virus (HAV) serological assays.
21:8.0.1.1.20.4.1.36SECTION 866.3320
   866.3320 Histoplasma capsulatum serological reagents.
21:8.0.1.1.20.4.1.37SECTION 866.3328
   866.3328 Influenza virus antigen detection test system.
21:8.0.1.1.20.4.1.38SECTION 866.3330
   866.3330 Influenza virus serological reagents.
21:8.0.1.1.20.4.1.39SECTION 866.3332
   866.3332 Reagents for detection of specific novel influenza A viruses.
21:8.0.1.1.20.4.1.40SECTION 866.3336
   866.3336 John Cunningham Virus serological reagents.
21:8.0.1.1.20.4.1.41SECTION 866.3340
   866.3340 Klebsiella spp. serological reagents.
21:8.0.1.1.20.4.1.42SECTION 866.3350
   866.3350 Leptospira spp. serological reagents.
21:8.0.1.1.20.4.1.43SECTION 866.3355
   866.3355 Listeria spp. serological reagents.
21:8.0.1.1.20.4.1.44SECTION 866.3360
   866.3360 Lymphocytic choriomeningitis virus serological reagents.
21:8.0.1.1.20.4.1.45SECTION 866.3361
   866.3361 Mass spectrometer system for clinical use for the identification of microorganisms.
21:8.0.1.1.20.4.1.46SECTION 866.3365
   866.3365 Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
21:8.0.1.1.20.4.1.47SECTION 866.3370
   866.3370 Mycobacterium tuberculosis immunofluorescent reagents.
21:8.0.1.1.20.4.1.48SECTION 866.3372
   866.3372 Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens.
21:8.0.1.1.20.4.1.49SECTION 866.3373
   866.3373 Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens.
21:8.0.1.1.20.4.1.50SECTION 866.3375
   866.3375 Mycoplasma spp. serological reagents.
21:8.0.1.1.20.4.1.51SECTION 866.3380
   866.3380 Mumps virus serological reagents.
21:8.0.1.1.20.4.1.52SECTION 866.3390
   866.3390 Neisseria spp. direct serological test reagents.
21:8.0.1.1.20.4.1.53SECTION 866.3395
   866.3395 Norovirus serological reagents.
21:8.0.1.1.20.4.1.54SECTION 866.3400
   866.3400 Parainfluenza virus serological reagents.
21:8.0.1.1.20.4.1.55SECTION 866.3402
   866.3402 Plasmodium species antigen detection assays.
21:8.0.1.1.20.4.1.56SECTION 866.3405
   866.3405 Poliovirus serological reagents.
21:8.0.1.1.20.4.1.57SECTION 866.3410
   866.3410 Proteus spp. (Weil-Felix) serological reagents.
21:8.0.1.1.20.4.1.58SECTION 866.3415
   866.3415 Pseudomonas spp. serological reagents.
21:8.0.1.1.20.4.1.59SECTION 866.3460
   866.3460 Rabiesvirus immunofluorescent reagents.
21:8.0.1.1.20.4.1.60SECTION 866.3470
   866.3470 Reovirus serological reagents.
21:8.0.1.1.20.4.1.61SECTION 866.3480
   866.3480 Respiratory syncytial virus serological reagents.
21:8.0.1.1.20.4.1.62SECTION 866.3490
   866.3490 Rhinovirus serological reagents.
21:8.0.1.1.20.4.1.63SECTION 866.3500
   866.3500 Rickettsia serological reagents.
21:8.0.1.1.20.4.1.64SECTION 866.3510
   866.3510 Rubella virus serological reagents.
21:8.0.1.1.20.4.1.65SECTION 866.3520
   866.3520 Rubeola (measles) virus serological reagents.
21:8.0.1.1.20.4.1.66SECTION 866.3550
   866.3550 Salmonella spp. serological reagents.
21:8.0.1.1.20.4.1.67SECTION 866.3600
   866.3600 Schistosoma spp. serological reagents.
21:8.0.1.1.20.4.1.68SECTION 866.3630
   866.3630 Serratia spp. serological reagents.
21:8.0.1.1.20.4.1.69SECTION 866.3660
   866.3660 Shigella spp. serological reagents.
21:8.0.1.1.20.4.1.70SECTION 866.3680
   866.3680 Sporothrix schenckii serological reagents.
21:8.0.1.1.20.4.1.71SECTION 866.3700
   866.3700 Staphylococcus aureus serological reagents.
21:8.0.1.1.20.4.1.72SECTION 866.3720
   866.3720 Streptococcus spp. exoenzyme reagents.
21:8.0.1.1.20.4.1.73SECTION 866.3740
   866.3740 Streptococcus spp. serological reagents.
21:8.0.1.1.20.4.1.74SECTION 866.3780
   866.3780 Toxoplasma gondii serological reagents.
21:8.0.1.1.20.4.1.75SECTION 866.3820
   866.3820 Treponema pallidum nontreponemal test reagents.
21:8.0.1.1.20.4.1.76SECTION 866.3830
   866.3830 Treponema pallidum treponemal test reagents.
21:8.0.1.1.20.4.1.77SECTION 866.3850
   866.3850 Trichinella spiralis serological reagents.
21:8.0.1.1.20.4.1.78SECTION 866.3860
   866.3860 Trichomonas vaginalis nucleic acid assay.
21:8.0.1.1.20.4.1.79SECTION 866.3870
   866.3870 Trypanosoma spp. serological reagents.
21:8.0.1.1.20.4.1.80SECTION 866.3900
   866.3900 Varicella-zoster virus serological reagents.
21:8.0.1.1.20.4.1.81SECTION 866.3920
   866.3920 Assayed quality control material for clinical microbiology assays.
21:8.0.1.1.20.4.1.82SECTION 866.3930
   866.3930 Vibrio cholerae serological reagents.
21:8.0.1.1.20.4.1.83SECTION 866.3940
   866.3940 West Nile virus serological reagents.
21:8.0.1.1.20.4.1.84SECTION 866.3945
   866.3945 Dengue virus serological reagents.
21:8.0.1.1.20.4.1.85SECTION 866.3946
   866.3946 Dengue virus nucleic acid amplification test reagents.
21:8.0.1.1.20.4.1.86SECTION 866.3950
   866.3950 In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.
21:8.0.1.1.20.4.1.87SECTION 866.3955
   866.3955 Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology.
21:8.0.1.1.20.4.1.88SECTION 866.3960
   866.3960 Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.
21:8.0.1.1.20.4.1.89SECTION 866.3970
   866.3970 Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.
21:8.0.1.1.20.4.1.90SECTION 866.3980
   866.3980 Respiratory viral panel multiplex nucleic acid assay.
21:8.0.1.1.20.4.1.91SECTION 866.3985
   866.3985 Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
21:8.0.1.1.20.4.1.92SECTION 866.3990
   866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay.
21:8.0.1.1.20.5SUBPART E
Subpart E - Immunology Laboratory Equipment and Reagents
21:8.0.1.1.20.5.1.1SECTION 866.4070
   866.4070 RNA Preanalytical Systems.
21:8.0.1.1.20.5.1.2SECTION 866.4100
   866.4100 Complement reagent.
21:8.0.1.1.20.5.1.3SECTION 866.4500
   866.4500 Immunoelectrophoresis equipment.
21:8.0.1.1.20.5.1.4SECTION 866.4520
   866.4520 Immunofluorometer equipment.
21:8.0.1.1.20.5.1.5SECTION 866.4540
   866.4540 Immunonephelometer equipment.
21:8.0.1.1.20.5.1.6SECTION 866.4600
   866.4600 Ouchterlony agar plate.
21:8.0.1.1.20.5.1.7SECTION 866.4700
   866.4700 Automated fluorescence in situ hybridization (FISH) enumeration systems.
21:8.0.1.1.20.5.1.8SECTION 866.4750
   866.4750 Automated indirect immunofluorescence microscope and software-assisted system.
21:8.0.1.1.20.5.1.9SECTION 866.4800
   866.4800 Radial immunodiffusion plate.
21:8.0.1.1.20.5.1.10SECTION 866.4830
   866.4830 Rocket immunoelectrophoresis equipment.
21:8.0.1.1.20.5.1.11SECTION 866.4900
   866.4900 Support gel.
21:8.0.1.1.20.6SUBPART F
Subpart F - Immunological Test Systems
21:8.0.1.1.20.6.1.1SECTION 866.5040
   866.5040 Albumin immunological test system.
21:8.0.1.1.20.6.1.2SECTION 866.5060
   866.5060 Prealbumin immunological test system.
21:8.0.1.1.20.6.1.3SECTION 866.5065
   866.5065 Human allotypic marker immunological test system.
21:8.0.1.1.20.6.1.4SECTION 866.5080
   866.5080 Alpha-1-antichymotrypsin immunological test system.
21:8.0.1.1.20.6.1.5SECTION 866.5090
   866.5090 Antimitochondrial antibody immunological test system.
21:8.0.1.1.20.6.1.6SECTION 866.5100
   866.5100 Antinuclear antibody immunological test system.
21:8.0.1.1.20.6.1.7SECTION 866.5110
   866.5110 Antiparietal antibody immunological test system.
21:8.0.1.1.20.6.1.8SECTION 866.5120
   866.5120 Antismooth muscle antibody immunological test system.
21:8.0.1.1.20.6.1.9SECTION 866.5130
   866.5130 Alpha-1-antitrypsin immunological test system.
21:8.0.1.1.20.6.1.10SECTION 866.5150
   866.5150 Bence-Jones proteins immunological test system.
21:8.0.1.1.20.6.1.11SECTION 866.5160
   866.5160 Beta-globulin immunological test system.
21:8.0.1.1.20.6.1.12SECTION 866.5170
   866.5170 Breast milk immunological test system.
21:8.0.1.1.20.6.1.13SECTION 866.5180
   866.5180 Fecal calprotectin immunological test system.
21:8.0.1.1.20.6.1.14SECTION 866.5200
   866.5200 Carbonic anhydrase B and C immunological test system.
21:8.0.1.1.20.6.1.15SECTION 866.5210
   866.5210 Ceruloplasmin immunological test system.
21:8.0.1.1.20.6.1.16SECTION 866.5220
   866.5220 Cohn fraction II immunological test system.
21:8.0.1.1.20.6.1.17SECTION 866.5230
   866.5230 Colostrum immunological test system.
21:8.0.1.1.20.6.1.18SECTION 866.5240
   866.5240 Complement components immunological test system.
21:8.0.1.1.20.6.1.19SECTION 866.5250
   866.5250 Complement C1 inhibitor (inactivator) immunological test system.
21:8.0.1.1.20.6.1.20SECTION 866.5260
   866.5260 Complement C3b inactivator immunological test system.
21:8.0.1.1.20.6.1.21SECTION 866.5270
   866.5270 C-reactive protein immunological test system.
21:8.0.1.1.20.6.1.22SECTION 866.5320
   866.5320 Properdin factor B immunological test system.
21:8.0.1.1.20.6.1.23SECTION 866.5330
   866.5330 Factor XIII, A, S, immunological test system.
21:8.0.1.1.20.6.1.24SECTION 866.5340
   866.5340 Ferritin immunological test system.
21:8.0.1.1.20.6.1.25SECTION 866.5350
   866.5350 Fibrinopeptide A immunological test system.
21:8.0.1.1.20.6.1.26SECTION 866.5360
   866.5360 Cohn fraction IV immunological test system.
21:8.0.1.1.20.6.1.27SECTION 866.5370
   866.5370 Cohn fraction V immunological test system.
21:8.0.1.1.20.6.1.28SECTION 866.5380
   866.5380 Free secretory component immunological test system.
21:8.0.1.1.20.6.1.29SECTION 866.5400
   866.5400 Alpha-globulin immunological test system.
21:8.0.1.1.20.6.1.30SECTION 866.5420
   866.5420 Alpha-1-glycoproteins immunological test system.
21:8.0.1.1.20.6.1.31SECTION 866.5425
   866.5425 Alpha-2-glycoproteins immunological test system.
21:8.0.1.1.20.6.1.32SECTION 866.5430
   866.5430 Beta-2-glycoprotein I immunological test system.
21:8.0.1.1.20.6.1.33SECTION 866.5440
   866.5440 Beta-2-glycoprotein III immunological test system.
21:8.0.1.1.20.6.1.34SECTION 866.5460
   866.5460 Haptoglobin immunological test system.
21:8.0.1.1.20.6.1.35SECTION 866.5470
   866.5470 Hemoglobin immunological test system.
21:8.0.1.1.20.6.1.36SECTION 866.5490
   866.5490 Hemopexin immunological test system.
21:8.0.1.1.20.6.1.37SECTION 866.5500
   866.5500 Hypersensitivity pneumonitis immunological test system.
21:8.0.1.1.20.6.1.38SECTION 866.5510
   866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
21:8.0.1.1.20.6.1.39SECTION 866.5520
   866.5520 Immunoglobulin G (Fab fragment specific) immunological test system.
21:8.0.1.1.20.6.1.40SECTION 866.5530
   866.5530 Immunoglobulin G (Fc fragment specific) immunological test system.
21:8.0.1.1.20.6.1.41SECTION 866.5540
   866.5540 Immunoglobulin G (Fd fragment specific) immunological test system.
21:8.0.1.1.20.6.1.42SECTION 866.5550
   866.5550 Immunoglobulin (light chain specific) immunological test system.
21:8.0.1.1.20.6.1.43SECTION 866.5560
   866.5560 Lactic dehydrogenase immunological test system.
21:8.0.1.1.20.6.1.44SECTION 866.5570
   866.5570 Lactoferrin immunological test system.
21:8.0.1.1.20.6.1.45SECTION 866.5580
   866.5580 Alpha-1-lipoprotein immunological test system.
21:8.0.1.1.20.6.1.46SECTION 866.5590
   866.5590 Lipoprotein X immunological test system.
21:8.0.1.1.20.6.1.47SECTION 866.5600
   866.5600 Low-density lipoprotein immunological test system.
21:8.0.1.1.20.6.1.48SECTION 866.5620
   866.5620 Alpha-2-macroglobulin immunological test system.
21:8.0.1.1.20.6.1.49SECTION 866.5630
   866.5630 Beta-2-microglobulin immunological test system.
21:8.0.1.1.20.6.1.50SECTION 866.5640
   866.5640 Infectious mononucleosis immunological test system.
21:8.0.1.1.20.6.1.51SECTION 866.5660
   866.5660 Multiple autoantibodies immunological test system.
21:8.0.1.1.20.6.1.52SECTION 866.5665
   866.5665 Aquaporin-4 autoantibody immunological test system.
21:8.0.1.1.20.6.1.53SECTION 866.5670
   866.5670 Zinc transporter 8 autoantibody immunological test system.
21:8.0.1.1.20.6.1.54SECTION 866.5680
   866.5680 Myoglobin immunological test system.
21:8.0.1.1.20.6.1.55SECTION 866.5700
   866.5700 Whole human plasma or serum immunological test system.
21:8.0.1.1.20.6.1.56SECTION 866.5715
   866.5715 Plasminogen immunological test system.
21:8.0.1.1.20.6.1.57SECTION 866.5735
   866.5735 Prothrombin immunological test system.
21:8.0.1.1.20.6.1.58SECTION 866.5750
   866.5750 Radioallergosorbent (RAST) immunological test system.
21:8.0.1.1.20.6.1.59SECTION 866.5760
   866.5760 Tryptase test system.
21:8.0.1.1.20.6.1.60SECTION 866.5765
   866.5765 Retinol-binding protein immunological test system.
21:8.0.1.1.20.6.1.61SECTION 866.5775
   866.5775 Rheumatoid factor immunological test system.
21:8.0.1.1.20.6.1.62SECTION 866.5785
   866.5785 Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems.
21:8.0.1.1.20.6.1.63SECTION 866.5800
   866.5800 Seminal fluid (sperm) immunological test system.
21:8.0.1.1.20.6.1.64SECTION 866.5820
   866.5820 Systemic lupus erythematosus immunological test system.
21:8.0.1.1.20.6.1.65SECTION 866.5830
   866.5830 Brain trauma assessment test.
21:8.0.1.1.20.6.1.66SECTION 866.5860
   866.5860 Total spinal fluid immunological test system.
21:8.0.1.1.20.6.1.67SECTION 866.5870
   866.5870 Thyroid autoantibody immunological test system.
21:8.0.1.1.20.6.1.68SECTION 866.5880
   866.5880 Transferrin immunological test system.
21:8.0.1.1.20.6.1.69SECTION 866.5890
   866.5890 Inter-alpha trypsin inhibitor immunological test system.
21:8.0.1.1.20.6.1.70SECTION 866.5900
   866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
21:8.0.1.1.20.6.1.71SECTION 866.5910
   866.5910 Quality control material for cystic fibrosis nucleic acid assays.
21:8.0.1.1.20.6.1.72SECTION 866.5930
   866.5930 Newborn screening test for severe combined immunodeficiency disorder (SCID).
21:8.0.1.1.20.6.1.73SECTION 866.5940
   866.5940 Autosomal recessive carrier screening gene mutation detection system.
21:8.0.1.1.20.6.1.74SECTION 866.5950
   866.5950 Genetic health risk assessment system.
21:8.0.1.1.20.7SUBPART G
Subpart G - Tumor Associated Antigen immunological Test Systems
21:8.0.1.1.20.7.1.1SECTION 866.6010
   866.6010 Tumor-associated antigen immunological test system.
21:8.0.1.1.20.7.1.2SECTION 866.6020
   866.6020 Immunomagnetic circulating cancer cell selection and enumeration system.
21:8.0.1.1.20.7.1.3SECTION 866.6030
   866.6030 AFP-L3% immunological test system.
21:8.0.1.1.20.7.1.4SECTION 866.6040
   866.6040 Gene expression profiling test system for breast cancer prognosis.
21:8.0.1.1.20.7.1.5SECTION 866.6050
   866.6050 Ovarian adnexal mass assessment score test system.
21:8.0.1.1.20.7.1.6SECTION 866.6060
   866.6060 BCR-ABL quantitation test.
21:8.0.1.1.20.7.1.7SECTION 866.6080
   866.6080 Next generation sequencing based tumor profiling test.