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Title 21

Displaying title 21, up to date as of 7/16/2026. Title 21 was last amended 7/09/2026.
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  1. Title 21 —Food and Drugs
  2. Chapter I —Food and Drug Administration, Department of Health and Human Services
  3. Subchapter H —Medical Devices
  4. Part 866 —Immunology and Microbiology Devices
  5. Subpart D   View Full Text
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eCFR Content

The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. It is not an official legal edition of the CFR.

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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter HMedical Devices800 – 898
Part 866Immunology and Microbiology Devices866.1 – 866.6110
Subpart DSerological Reagents866.3010 – 866.4001
§ 866.3010Acinetobacter calcoaceticus serological reagents.
§ 866.3020Adenovirus serological reagents.
§ 866.3035Arizona spp. serological reagents.
§ 866.3040Aspergillus spp. serological reagents.
§ 866.3045In vitro diagnostic device for Bacillus spp. detection.
§ 866.3046Simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples.
§ 866.3050Beta-glucan serological assays.
§ 866.3060Blastomyces dermatitidis serological reagents.
§ 866.3065Bordetella spp. serological reagents.
§ 866.3085Brucella spp. serological reagents.
§ 866.3110Campylobacter fetus serological reagents.
§ 866.3120Chlamydia serological reagents.
§ 866.3125Citrobacter spp. serological reagents.
§ 866.3130Clostridium difficile toxin gene amplification assay.
§ 866.3135Coccidioides immitis serological reagents.
§ 866.3140Corynebacterium spp. serological reagents.
§ 866.3145Coxsackievirus serological reagents.
§ 866.3165Cryptococcus neoformans 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.
§ 866.3200Echinococcus 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.
§ 866.3220Entamoeba histolytica 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.
§ 866.3250Erysipelothrix rhusiopathiae serological reagents.
§ 866.3255Escherichia coli serological reagents.
§ 866.3270Flavobacterium spp. serological reagents.
§ 866.3280Francisella tularensis serological reagents.
§ 866.3290Gonococcal antibody test (GAT).
§ 866.3300Haemophilus 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.
§ 866.3320Histoplasma capsulatum 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.
§ 866.3340Klebsiella spp. serological reagents.
§ 866.3350Leptospira spp. serological reagents.
§ 866.3355Listeria 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.
§ 866.3370Mycobacterium tuberculosis 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.
§ 866.3375Mycoplasma 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.
§ 866.3390Neisseria 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.
§ 866.3410Proteus spp. (Weil-Felix) serological reagents.
§ 866.3415Pseudomonas 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.
§ 866.3550Salmonella spp. serological reagents.
§ 866.3600Schistosoma spp. serological reagents.
§ 866.3630Serratia spp. serological reagents.
§ 866.3660Shigella spp. serological reagents.
§ 866.3680Sporothrix schenckii serological reagents.
§ 866.3700Staphylococcus aureus serological reagents.
§ 866.3720Streptococcus spp. exoenzyme reagents.
§ 866.3740Streptococcus spp. serological reagents.
§ 866.3780Toxoplasma gondii serological reagents.
§ 866.3820Treponema pallidum nontreponemal test reagents.
§ 866.3830Treponema pallidum treponemal test reagents.
§ 866.3850Trichinella spiralis serological reagents.
§ 866.3860Trichomonas vaginalis nucleic acid assay.
§ 866.3870Trypanosoma spp. serological reagents.
§ 866.3900Varicella-zoster virus serological reagents.
§ 866.3920Assayed quality control material for clinical microbiology assays.
§ 866.3930Vibrio cholerae 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.
§ 866.3982Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings.
§ 866.3983SARS-CoV-2 serology test.
§ 866.3985Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
§ 866.3988Device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection.
§ 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.
eCFR Content