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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 866 - Immunology and Microbiology Devices |
| Subpart A - General Provisions |
| § 866.1 - Scope. |
| § 866.3 - Effective dates of requirement for premarket approval. |
| § 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
| Subpart B - Diagnostic Devices |
| § 866.1620 - Antimicrobial susceptibility test disc. |
| § 866.1640 - Antimicrobial susceptibility test powder. |
| § 866.1645 - Fully automated short-term incubation cycle antimicrobial susceptibility system. |
| § 866.1655 - System for detection of microorganisms and antimicrobial resistance using reporter expression. |
| § 866.1700 - Culture medium for antimicrobial susceptibility tests. |
| Subpart C - Microbiology Devices |
| § 866.2050 - Staphylococcal typing bacteriophage. |
| § 866.2120 - Anaerobic chamber. |
| § 866.2160 - Coagulase plasma. |
| § 866.2170 - Automated colony counter. |
| § 866.2180 - Manual colony counter. |
| § 866.2190 - Automated image assessment system for microbial colonies on solid culture media. |
| § 866.2300 - Multipurpose culture medium. |
| § 866.2320 - Differential culture medium. |
| § 866.2330 - Enriched culture medium. |
| § 866.2350 - Microbiological assay culture medium. |
| § 866.2360 - Selective culture medium. |
| § 866.2390 - Transport culture medium. |
| § 866.2410 - Culture medium for pathogenic Neisseria spp. |
| § 866.2420 - Oxidase screening test for gonorrhea. |
| § 866.2440 - Automated medium dispensing and stacking device. |
| § 866.2450 - Supplement for culture media. |
| § 866.2480 - Quality control kit for culture media. |
| § 866.2500 - Microtiter diluting and dispensing device. |
| § 866.2540 - Microbiological incubator. |
| § 866.2560 - Microbial growth monitor. |
| § 866.2580 - Gas-generating device. |
| § 866.2600 - Wood's fluorescent lamp. |
| § 866.2660 - Microorganism differentiation and identification device. |
| § 866.2680 - Streptococcus spp. nucleic acid-based assay. |
| § 866.2850 - Automated zone reader. |
| § 866.2900 - Microbiological specimen collection and transport device. |
| Subpart D - Serological Reagents |
| § 866.3010 - Acinetobacter calcoaceticus serological reagents. |
| § 866.3020 - Adenovirus serological reagents. |
| § 866.3035 - Arizona spp. serological reagents. |
| § 866.3040 - Aspergillus spp. serological reagents. |
| § 866.3045 - xxx |
| § 866.3050 - Beta-glucan serological assays. |
| § 866.3060 - Blastomyces dermatitidis serological reagents. |
| § 866.3065 - Bordetella spp. serological reagents. |
| § 866.3085 - Brucella spp. serological reagents. |
| § 866.3110 - Campylobacter fetus serological reagents. |
| § 866.3120 - Chlamydia serological reagents. |
| § 866.3125 - Citrobacter spp. serological reagents. |
| § 866.3130 - Clostridium difficile toxin gene amplification assay. |
| § 866.3135 - Coccidioides immitis serological reagents. |
| § 866.3140 - Corynebacterium spp. serological reagents. |
| § 866.3145 - Coxsackievirus serological reagents. |
| § 866.3165 - Cryptococcus neoformans serological reagents. |
| § 866.3169 - xxx |
| § 866.3170 - xxx |
| § 866.3175 - Cytomegalovirus serological reagents. |
| § 866.3200 - Echinococcus spp. serological reagents. |
| § 866.3205 - Echovirus serological reagents. |
| § 866.3210 - Endotoxin assay. |
| § 866.3215 - Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis. |
| § 866.3220 - Entamoeba histolytica serological reagents. |
| § 866.3225 - Enterovirus nucleic acid assay. |
| § 866.3235 - Epstein-Barr virus serological reagents. |
| § 866.3240 - Equine encephalomyelitis virus serological reagents. |
| § 866.3250 - Erysipelothrix rhusiopathiae serological reagents. |
| § 866.3255 - Escherichia coli serological reagents. |
| § 866.3270 - Flavobacterium spp. serological reagents. |
| § 866.3280 - Francisella tularensis serological reagents. |
| § 866.3290 - Gonococcal antibody test (GAT). |
| § 866.3300 - Haemophilus spp. serological reagents. |
| § 866.3305 - Herpes simplex virus serological assays. |
| § 866.3309 - Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel. |
| § 866.3310 - Hepatitis A virus (HAV) serological assays. |
| § 866.3320 - Histoplasma capsulatum serological reagents. |
| § 866.3328 - xxx |
| § 866.3330 - Influenza virus serological reagents. |
| § 866.3332 - Reagents for detection of specific novel influenza A viruses. |
| § 866.3336 - John Cunningham Virus serological reagents. |
| § 866.3340 - Klebsiella spp. serological reagents. |
| § 866.3350 - Leptospira spp. serological reagents. |
| § 866.3355 - Listeria spp. serological reagents. |
| § 866.3360 - Lymphocytic choriomeningitis virus serological reagents. |
| § 866.3361 - Mass spectrometer system for clinical use for the identification of microorganisms. |
| § 866.3365 - Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures. |
| § 866.3370 - Mycobacterium tuberculosis immunofluorescent reagents. |
| § 866.3372 - Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens. |
| § 866.3375 - Mycoplasma spp. serological reagents. |
| § 866.3380 - Mumps virus serological reagents. |
| § 866.3390 - Neisseria spp. direct serological test reagents. |
| § 866.3395 - Norovirus serological reagents. |
| § 866.3400 - Parainfluenza virus serological reagents. |
| § 866.3402 - Plasmodium species antigen detection assays. |
| § 866.3405 - Poliovirus serological reagents. |
| § 866.3410 - Proteus spp. (Weil-Felix) serological reagents. |
| § 866.3415 - Pseudomonas spp. serological reagents. |
| § 866.3460 - Rabiesvirus immunofluorescent reagents. |
| § 866.3470 - Reovirus serological reagents. |
| § 866.3480 - Respiratory syncytial virus serological reagents. |
| § 866.3490 - Rhinovirus serological reagents. |
| § 866.3500 - Rickettsia serological reagents. |
| § 866.3510 - Rubella virus serological reagents. |
| § 866.3520 - Rubeola (measles) virus serological reagents. |
| § 866.3550 - Salmonella spp. serological reagents. |
| § 866.3600 - Schistosoma spp. serological reagents. |
| § 866.3610 - Endotoxin assay. |
| § 866.3630 - Serratia spp. serological reagents. |
| § 866.3660 - Shigella spp. serological reagents. |
| § 866.3680 - Sporothrix schenckii serological reagents. |
| § 866.3700 - Staphylococcus aureus serological reagents. |
| § 866.3720 - Streptococcus spp. exoenzyme reagents. |
| § 866.3740 - Streptococcus spp. serological reagents. |
| § 866.3780 - Toxoplasma gondii serological reagents. |
| § 866.3820 - Treponema pallidum nontreponemal test reagents. |
| § 866.3830 - Treponema pallidum treponemal test reagents. |
| § 866.3850 - Trichinella spiralis serological reagents. |
| § 866.3860 - Trichomonas vaginalis nucleic acid assay. |
| § 866.3870 - Trypanosoma spp. serological reagents. |
| § 866.3900 - Varicella-zoster virus serological reagents. |
| § 866.3920 - Assayed quality control material for clinical microbiology assays. |
| § 866.3930 - Vibrio cholerae serological reagents. |
| § 866.3940 - West Nile virus serological reagents. |
| § 866.3945 - Dengue virus serological reagents. |
| § 866.3946 - Dengue virus nucleic acid amplification test reagents. |
| § 866.3950 - In vitro human immunodeficiency virus (HIV) drug resistance genotype assay. |
| § 866.3955 - Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology. |
| § 866.3956 - xxx |
| § 866.3957 - xxx |
| § 866.3958 - Human immunodeficiency virus (HIV) viral load monitoring test. |
| § 866.3960 - Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens. |
| § 866.3970 - Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid. |
| § 866.3980 - Respiratory viral panel multiplex nucleic acid assay. |
| § 866.3985 - Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens. |
| § 866.3990 - Gastrointestinal microorganism multiplex nucleic acid-based assay. |
| Subpart E - Immunology Laboratory Equipment and Reagents |
| § 866.4070 - RNA Preanalytical Systems. |
| § 866.4100 - Complement reagent. |
| § 866.4500 - Immunoelectrophoresis equipment. |
| § 866.4520 - Immunofluorometer equipment. |
| § 866.4540 - Immunonephelometer equipment. |
| § 866.4600 - Ouchterlony agar plate. |
| § 866.4700 - Automated fluorescence in situ hybridization (FISH) enumeration systems. |
| § 866.4750 - Automated indirect immunofluorescence microscope and software-assisted system. |
| § 866.4800 - Radial immunodiffusion plate. |
| § 866.4830 - Rocket immunoelectrophoresis equipment. |
| § 866.4900 - Support gel. |
| Subpart F - Immunological Test Systems |
| § 866.5040 - Albumin immunological test system. |
| § 866.5060 - Prealbumin immunological test system. |
| § 866.5065 - Human allotypic marker immunological test system. |
| § 866.5080 - Alpha-1-antichymotrypsin immunological test system. |
| § 866.5090 - Antimitochondrial antibody immunological test system. |
| § 866.5100 - Antinuclear antibody immunological test system. |
| § 866.5110 - Antiparietal antibody immunological test system. |
| § 866.5120 - Antismooth muscle antibody immunological test system. |
| § 866.5130 - Alpha-1-antitrypsin immunological test system. |
| § 866.5150 - Bence-Jones proteins immunological test system. |
| § 866.5160 - Beta-globulin immunological test system. |
| § 866.5170 - Breast milk immunological test system. |
| § 866.5180 - Fecal calprotectin immunological test system. |
| § 866.5200 - Carbonic anhydrase B and C immunological test system. |
| § 866.5210 - Ceruloplasmin immunological test system. |
| § 866.5220 - Cohn fraction II immunological test system. |
| § 866.5230 - Colostrum immunological test system. |
| § 866.5240 - Complement components immunological test system. |
| § 866.5250 - Complement C1 inhibitor (inactivator) immunological test system. |
| § 866.5260 - Complement C3b inactivator immunological test system. |
| § 866.5270 - C-reactive protein immunological test system. |
| § 866.5320 - Properdin factor B immunological test system. |
| § 866.5330 - Factor XIII, A, S, immunological test system. |
| § 866.5340 - Ferritin immunological test system. |
| § 866.5350 - Fibrinopeptide A immunological test system. |
| § 866.5360 - Cohn fraction IV immunological test system. |
| § 866.5370 - Cohn fraction V immunological test system. |
| § 866.5380 - Free secretory component immunological test system. |
| § 866.5400 - Alpha-globulin immunological test system. |
| § 866.5420 - Alpha-1-glycoproteins immunological test system. |
| § 866.5425 - Alpha-2-glycoproteins immunological test system. |
| § 866.5430 - Beta-2-glycoprotein I immunological test system. |
| § 866.5440 - Beta-2-glycoprotein III immunological test system. |
| § 866.5460 - Haptoglobin immunological test system. |
| § 866.5470 - Hemoglobin immunological test system. |
| § 866.5490 - Hemopexin immunological test system. |
| § 866.5500 - Hypersensitivity pneumonitis immunological test system. |
| § 866.5510 - Immunoglobulins A, G, M, D, and E immunological test system. |
| § 866.5520 - Immunoglobulin G (Fab fragment specific) immunological test system. |
| § 866.5530 - Immunoglobulin G (Fc fragment specific) immunological test system. |
| § 866.5540 - Immunoglobulin G (Fd fragment specific) immunological test system. |
| § 866.5550 - Immunoglobulin (light chain specific) immunological test system. |
| § 866.5560 - Lactic dehydrogenase immunological test system. |
| § 866.5570 - Lactoferrin immunological test system. |
| § 866.5580 - Alpha-1-lipoprotein immunological test system. |
| § 866.5590 - Lipoprotein X immunological test system. |
| § 866.5600 - Low-density lipoprotein immunological test system. |
| § 866.5620 - Alpha-2-macroglobulin immunological test system. |
| § 866.5630 - Beta-2-microglobulin immunological test system. |
| § 866.5640 - Infectious mononucleosis immunological test system. |
| § 866.5660 - Multiple autoantibodies immunological test system. |
| § 866.5665 - Aquaporin-4 autoantibody immunological test system. |
| § 866.5670 - Zinc transporter 8 autoantibody immunological test system. |
| § 866.5680 - Myoglobin immunological test system. |
| § 866.5700 - Whole human plasma or serum immunological test system. |
| § 866.5715 - Plasminogen immunological test system. |
| § 866.5735 - Prothrombin immunological test system. |
| § 866.5750 - Radioallergosorbent (RAST) immunological test system. |
| § 866.5760 - Tryptase test system. |
| § 866.5765 - Retinol-binding protein immunological test system. |
| § 866.5775 - Rheumatoid factor immunological test system. |
| § 866.5785 - Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems. |
| § 866.5800 - Seminal fluid (sperm) immunological test system. |
| § 866.5820 - Systemic lupus erythematosus immunological test system. |
| § 866.5830 - Brain trauma assessment test. |
| § 866.5860 - Total spinal fluid immunological test system. |
| § 866.5870 - Thyroid autoantibody immunological test system. |
| § 866.5880 - Transferrin immunological test system. |
| § 866.5890 - Inter-alpha trypsin inhibitor immunological test system. |
| § 866.5900 - Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system. |
| § 866.5910 - Quality control material for cystic fibrosis nucleic acid assays. |
| § 866.5930 - Newborn screening test for severe combined immunodeficiency disorder (SCID). |
| § 866.5940 - Autosomal recessive carrier screening gene mutation detection system. |
| § 866.5950 - Genetic health risk assessment system. |
| § 866.5960 - Human leukocyte antigen typing companion diagnostic test. |
| Subpart G - Tumor Associated Antigen immunological Test Systems |
| § 866.6010 - Tumor-associated antigen immunological test system. |
| § 866.6020 - Immunomagnetic circulating cancer cell selection and enumeration system. |
| § 866.6030 - AFP-L3% immunological test system. |
| § 866.6040 - Gene expression profiling test system for breast cancer prognosis. |
| § 866.6050 - Ovarian adnexal mass assessment score test system. |
| § 866.6060 - BCR-ABL quantitation test. |
| § 866.6080 - Next generation sequencing based tumor profiling test. |