Home/CFR/Title 21/Part 866
FEDERAL · 21 CFR

Part 866 — Immunology and Microbiology Devices

252 sections · Title 21: Food and Drugs

§ 866.1Scope.
§ 866.3Effective dates of requirement for premarket approval.
§ 866.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 866.1620Antimicrobial susceptibility test disc.
§ 866.1640Antimicrobial susceptibility test powder.
§ 866.1645Fully automated short-term incubation cycle antimicrobial susceptibility system.
§ 866.1650A cellular analysis system for multiplexed antimicrobial susceptibility testing.
§ 866.1655System for detection of microorganisms and antimicrobial resistance using reporter expression.
§ 866.1700Culture medium for antimicrobial susceptibility tests.
§ 866.2050Staphylococcal typing bacteriophage.
§ 866.2120Anaerobic chamber.
§ 866.2160Coagulase plasma.
§ 866.2170Automated colony counter.
§ 866.2180Manual colony counter.
§ 866.2190Automated image assessment system for microbial colonies on solid culture media.
§ 866.2300Multipurpose culture medium.
§ 866.2320Differential culture medium.
§ 866.2330Enriched culture medium.
§ 866.2350Microbiological assay culture medium.
§ 866.2360Selective culture medium.
§ 866.2390Transport culture medium.
§ 866.2410Culture medium for pathogenic <em>Neisseria</em> spp.
§ 866.2420Oxidase screening test for gonorrhea.
§ 866.2440Automated medium dispensing and stacking device.
§ 866.2450Supplement for culture media.
§ 866.2480Quality control kit for culture media.
§ 866.2500Microtiter diluting and dispensing device.
§ 866.2540Microbiological incubator.
§ 866.2560Microbial growth monitor.
§ 866.2580Gas-generating device.
§ 866.2600Wood's fluorescent lamp.
§ 866.2660Microorganism differentiation and identification device.
§ 866.2680<em>Streptococcus spp.</em> nucleic acid-based assay.
§ 866.2850Automated zone reader.
§ 866.2900Microbiological specimen collection and transport device.
§ 866.2950Microbial nucleic acid storage and stabilization device.
§ 866.3010<em>Acinetobacter calcoaceticus</em> serological reagents.
§ 866.3020Adenovirus serological reagents.
§ 866.3035<em>Arizona</em> spp. serological reagents.
§ 866.3040<em>Aspergillus</em> spp. serological reagents.
§ 866.3045In vitro diagnostic device for <em>Bacillus</em> spp. detection.
§ 866.3050Beta-glucan serological assays.
§ 866.3060<em>Blastomyces dermatitidis</em> serological reagents.
§ 866.3065<em>Bordetella</em> spp. serological reagents.
§ 866.3085<em>Brucella</em> spp. serological reagents.
§ 866.3110<em>Campylobacter fetus</em> serological reagents.
§ 866.3120Chlamydia serological reagents.
§ 866.3125<em>Citrobacter</em> spp. serological reagents.
§ 866.3130Clostridium difficile toxin gene amplification assay.
§ 866.3135<em>Coccidioides immitis</em> serological reagents.
§ 866.3140<em>Corynebacterium</em> spp. serological reagents.
§ 866.3145Coxsackievirus serological reagents.
§ 866.3165<em>Cryptococcus neoformans</em> serological reagents.
§ 866.3169Hepatitis C virus antibody tests.
§ 866.3170Nucleic acid-based hepatitis C virus ribonucleic acid tests.
§ 866.3172Qualitative hepatitis B virus antigen assays.
§ 866.3173Hepatitis B virus antibody assays.
§ 866.3174Hepatitis B virus nucleic acid-based assays.
§ 866.3175Cytomegalovirus serological reagents.
§ 866.3180Quantitative cytomegalovirus nucleic acid tests for transplant patient management.
§ 866.3181Cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection.
§ 866.3183Quantitative viral nucleic acid test for transplant patient management.
§ 866.3200<em>Echinococcus</em> spp. serological reagents.
§ 866.3205Echovirus serological reagents.
§ 866.3210Endotoxin assay.
§ 866.3215Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
§ 866.3220<em>Entamoeba histolytica</em> serological reagents.
§ 866.3225Enterovirus nucleic acid assay.
§ 866.3230Device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections.
§ 866.3231Device to detect bacterial protease activity in chronic wound fluid.
§ 866.3235Epstein-Barr virus serological reagents.
§ 866.3236Device to detect or measure nucleic acid from viruses associated with head and neck cancers.
§ 866.3240Equine encephalomyelitis virus serological reagents.
§ 866.3250<em>Erysipelothrix rhusiopathiae</em> serological reagents.
§ 866.3255<em>Escherichia coli</em> serological reagents.
§ 866.3270<em>Flavobacterium</em> spp. serological reagents.
§ 866.3280<em>Francisella tularensis</em> serological reagents.
§ 866.3290Gonococcal antibody test (GAT).
§ 866.3300<em>Haemophilus</em> spp. serological reagents.
§ 866.3305Herpes simplex virus serological assays.
§ 866.3307Herpes simplex virus nucleic acid-based assay for central nervous system infections.
§ 866.3309Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
§ 866.3310Hepatitis A virus (HAV) serological assays.
§ 866.3320<em>Histoplasma capsulatum</em> serological reagents.
§ 866.3328Influenza virus antigen detection test system.
§ 866.3330Influenza virus serological reagents.
§ 866.3332Reagents for detection of specific novel influenza A viruses.
§ 866.3336John Cunningham Virus serological reagents.
§ 866.3340<em>Klebsiella</em> spp. serological reagents.
§ 866.3350<em>Leptospira</em> spp. serological reagents.
§ 866.3355<em>Listeria</em> spp. serological reagents.
§ 866.3360Lymphocytic choriomeningitis virus serological reagents.
§ 866.3361Mass spectrometer system for clinical use for the identification of microorganisms.
§ 866.3365Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
§ 866.3367Device to detect and identify microbial nucleic acids by FISH in clinical specimens.
§ 866.3370<em>Mycobacterium tuberculosis</em> immunofluorescent reagents.
§ 866.3372Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens.
§ 866.3373Nucleic 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.
§ 866.3375<em>Mycoplasma</em> spp. serological reagents.
§ 866.3376Device to detect and identify fungal nucleic acids directly in respiratory specimens.
§ 866.3378Clinical mass spectrometry microorganism identification and differentiation system.
§ 866.3380Mumps virus serological reagents.
§ 866.3390<em>Neisseria</em> spp. direct serological test reagents.
§ 866.3393Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s).
§ 866.3395Norovirus serological reagents.
§ 866.3400Parainfluenza virus serological reagents.
§ 866.3402Plasmodium species antigen detection assays.
§ 866.3405Poliovirus serological reagents.
§ 866.3410<em>Proteus</em> spp. (Weil-Felix) serological reagents.
§ 866.3415<em>Pseudomonas</em> spp. serological reagents.
§ 866.3460Rabiesvirus immunofluorescent reagents.
§ 866.3470Reovirus serological reagents.
§ 866.3480Respiratory syncytial virus serological reagents.
§ 866.3490Rhinovirus serological reagents.
§ 866.3500Rickettsia serological reagents.
§ 866.3510Rubella virus serological reagents.
§ 866.3520Rubeola (measles) virus serological reagents.
§ 866.3550<em>Salmonella</em> spp. serological reagents.
§ 866.3600<em>Schistosoma</em> spp. serological reagents.
§ 866.3630<em>Serratia</em> spp. serological reagents.
§ 866.3660<em>Shigella</em> spp. serological reagents.
§ 866.3680<em>Sporothrix schenckii</em> serological reagents.
§ 866.3700<em>Staphylococcus aureus</em> serological reagents.
§ 866.3720<em>Streptococcus</em> spp. exoenzyme reagents.
§ 866.3740<em>Streptococcus</em> spp. serological reagents.
§ 866.3780<em>Toxoplasma gondii</em> serological reagents.
§ 866.3820<em>Treponema pallidum</em> nontreponemal test reagents.
§ 866.3830<em>Treponema pallidum</em> treponemal test reagents.
§ 866.3850<em>Trichinella spiralis</em> serological reagents.
§ 866.3860<em>Trichomonas vaginalis</em> nucleic acid assay.
§ 866.3870<em>Trypanosoma</em> spp. serological reagents.
§ 866.3900Varicella-zoster virus serological reagents.
§ 866.3920Assayed quality control material for clinical microbiology assays.
§ 866.3930<em>Vibrio cholerae</em> serological reagents.
§ 866.3935Zika virus serological reagents.
§ 866.3940West Nile virus serological reagents.
§ 866.3945Dengue virus serological reagents.
§ 866.3946Dengue virus nucleic acid amplification test reagents.
§ 866.3950In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.
§ 866.3955Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology.
§ 866.3956Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test.
§ 866.3957Human immunodeficiency virus (HIV) nucleic acid (NAT) diagnostic and/or supplemental test.
§ 866.3958Human immunodeficiency virus (HIV) viral load monitoring test.
§ 866.3960Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.
§ 866.3966Device to detect and identify selected microbial agents that cause acute febrile illness.
§ 866.3970Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.
§ 866.3975Device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis.
§ 866.3980Respiratory viral panel multiplex nucleic acid assay.
§ 866.3981Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test.
§ 866.3985Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
§ 866.3990Gastrointestinal microorganism multiplex nucleic acid-based assay.
§ 866.4001A multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens.
§ 866.4070RNA Preanalytical Systems.
§ 866.4100Complement reagent.
§ 866.4500Immunoelectrophoresis equipment.
§ 866.4520Immunofluorometer equipment.
§ 866.4540Immunonephelometer equipment.
§ 866.4600Ouchterlony agar plate.
§ 866.4700Automated fluorescence <em>in situ</em> hybridization (FISH) enumeration systems.
§ 866.4750Automated indirect immunofluorescence microscope and software-assisted system.
§ 866.4800Radial immunodiffusion plate.
§ 866.4830Rocket immunoelectrophoresis equipment.
§ 866.4900Support gel.
§ 866.5040Albumin immunological test system.
§ 866.5060Prealbumin immunological test system.
§ 866.5065Human allotypic marker immunological test system.
§ 866.5080<em>Alpha</em>-1-antichymotrypsin immunological test system.
§ 866.5090Antimitochondrial antibody immunological test system.
§ 866.5100Antinuclear antibody immunological test system.
§ 866.5110Antiparietal antibody immunological test system.
§ 866.5120Antismooth muscle antibody immunological test system.
§ 866.5130<em>Alpha</em>-1-antitrypsin immunological test system.
§ 866.5150Bence-Jones proteins immunological test system.
§ 866.5160<em>Beta</em>-globulin immunological test system.
§ 866.5170Breast milk immunological test system.
§ 866.5180Fecal calprotectin immunological test system.
§ 866.5200Carbonic anhydrase B and C immunological test system.
§ 866.5210Ceruloplasmin immunological test system.
§ 866.5220Cohn fraction II immunological test system.
§ 866.5230Colostrum immunological test system.
§ 866.5240Complement components immunological test system.
§ 866.5250Complement C<sub>1</sub> inhibitor (inactivator) immunological test system.
§ 866.5260Complement C<sub>3b</sub> inactivator immunological test system.
§ 866.5270C-reactive protein immunological test system.
§ 866.5320Properdin factor B immunological test system.
§ 866.5330Factor XIII, A, S, immunological test system.
§ 866.5340Ferritin immunological test system.
§ 866.5350Fibrinopeptide A immunological test system.
§ 866.5360Cohn fraction IV immunological test system.
§ 866.5370Cohn fraction V immunological test system.
§ 866.5380Free secretory component immunological test system.
§ 866.5400<em>Alpha</em>-globulin immunological test system.
§ 866.5420<em>Alpha</em>-1-glycoproteins immunological test system.
§ 866.5425<em>Alpha</em>-2-glycoproteins immunological test system.
§ 866.5430<em>Beta</em>-2-glycoprotein I immunological test system.
§ 866.5440<em>Beta</em>-2-glycoprotein III immunological test system.
§ 866.5460Haptoglobin immunological test system.
§ 866.5470Hemoglobin immunological test system.
§ 866.5490Hemopexin immunological test system.
§ 866.5500Hypersensitivity pneumonitis immunological test system.
§ 866.5510Immunoglobulins A, G, M, D, and E immunological test system.
§ 866.5520Immunoglobulin G (Fab fragment specific) immunological test system.
§ 866.5530Immunoglobulin G (Fc fragment specific) immunological test system.
§ 866.5540Immunoglobulin G (Fd fragment specific) immunological test system.
§ 866.5550Immunoglobulin (light chain specific) immunological test system.
§ 866.5560Lactic dehydrogenase immunological test system.
§ 866.5570Lactoferrin immunological test system.
§ 866.5580<em>Alpha</em>-1-lipoprotein immunological test system.
§ 866.5590Lipoprotein X immunological test system.
§ 866.5600Low-density lipoprotein immunological test system.
§ 866.5620<em>Alpha</em>-2-macroglobulin immunological test system.
§ 866.5630<em>Beta</em>-2-microglobulin immunological test system.
§ 866.5640Infectious mononucleosis immunological test system.
§ 866.5660Multiple autoantibodies immunological test system.
§ 866.5665Aquaporin-4 autoantibody immunological test system.
§ 866.5670Zinc transporter 8 autoantibody immunological test system.
§ 866.5680Myoglobin immunological test system.
§ 866.5700Whole human plasma or serum immunological test system.
§ 866.5715Plasminogen immunological test system.
§ 866.5735Prothrombin immunological test system.
§ 866.5750Radioallergosorbent (RAST) immunological test system.
§ 866.5760Tryptase test system.
§ 866.5765Retinol-binding protein immunological test system.
§ 866.5775Rheumatoid factor immunological test system.
§ 866.5780Anti-phospholipase A2 receptor immunological test system.
§ 866.5785Anti-<em>Saccharomyces cerevisiae</em> (<em>S. cerevisiae</em>) antibody (ASCA) test systems.
§ 866.5800Seminal fluid (sperm) immunological test system.
§ 866.5820Systemic lupus erythematosus immunological test system.
§ 866.5830Brain trauma assessment test.
§ 866.5860Total spinal fluid immunological test system.
§ 866.5870Thyroid autoantibody immunological test system.
§ 866.5880Transferrin immunological test system.
§ 866.5890Inter-<em>alpha</em> trypsin inhibitor immunological test system.
§ 866.5900Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
§ 866.5910Quality control material for cystic fibrosis nucleic acid assays.
§ 866.5920Postnatal chromosomal copy number variation detection system.
§ 866.5930Newborn screening test for severe combined immunodeficiency disorder (SCID).
§ 866.5940Autosomal recessive carrier screening gene mutation detection system.
§ 866.5950Genetic health risk assessment system.
§ 866.5960Human leukocyte antigen typing companion diagnostic test.
§ 866.5970Inherited nucleotide repeat disorder DNA test.
§ 866.6000Whole exome sequencing constituent device.
§ 866.6010Tumor-associated antigen immunological test system.
§ 866.6020Immunomagnetic circulating cancer cell selection and enumeration system.
§ 866.6030AFP-L3% immunological test system.
§ 866.6040Gene expression profiling test system for breast cancer prognosis.
§ 866.6050Ovarian adnexal mass assessment score test system.
§ 866.6060BCR-ABL quantitation test.
§ 866.6070Mutation detection test for myeloproliferative neoplasms.
§ 866.6080Next generation sequencing based tumor profiling test.
§ 866.6090Cancer predisposition risk assessment system.
§ 866.6100DNA-based test to measure minimal residual disease in hematological malignancies.