Federal (United States) · Regulations
Subpart D
121 sections
121 sections
- 21 C.F.R. § 866.3010Acinetobacter calcoaceticus serological reagents.
- 21 C.F.R. § 866.3020Adenovirus serological reagents.
- 21 C.F.R. § 866.3035Arizona spp. serological reagents.
- 21 C.F.R. § 866.3040Aspergillus spp. serological reagents.
- 21 C.F.R. § 866.3045In vitro diagnostic device for Bacillus spp. detection.
- 21 C.F.R. § 866.3046Simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples.
- 21 C.F.R. § 866.3050Beta-glucan serological assays.
- 21 C.F.R. § 866.3060Blastomyces dermatitidis serological reagents.
- 21 C.F.R. § 866.3065Bordetella spp. serological reagents.
- 21 C.F.R. § 866.3085Brucella spp. serological reagents.
- 21 C.F.R. § 866.3110Campylobacter fetus serological reagents.
- 21 C.F.R. § 866.3120Chlamydia serological reagents.
- 21 C.F.R. § 866.3125Citrobacter spp. serological reagents.
- 21 C.F.R. § 866.3130Clostridium difficile toxin gene amplification assay.
- 21 C.F.R. § 866.3135Coccidioides immitis serological reagents.
- 21 C.F.R. § 866.3140Corynebacterium spp. serological reagents.
- 21 C.F.R. § 866.3145Coxsackievirus serological reagents.
- 21 C.F.R. § 866.3165Cryptococcus neoformans serological reagents.
- 21 C.F.R. § 866.3169Hepatitis C virus antibody tests.
- 21 C.F.R. § 866.3170Nucleic acid-based hepatitis C virus ribonucleic acid tests.
- 21 C.F.R. § 866.3172Qualitative hepatitis B virus antigen assays.
- 21 C.F.R. § 866.3173Hepatitis B virus antibody assays.
- 21 C.F.R. § 866.3174Hepatitis B virus nucleic acid-based assays.
- 21 C.F.R. § 866.3175Cytomegalovirus serological reagents.
- 21 C.F.R. § 866.3180Quantitative cytomegalovirus nucleic acid tests for transplant patient management.
- 21 C.F.R. § 866.3181Cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection.
- 21 C.F.R. § 866.3183Quantitative viral nucleic acid test for transplant patient management.
- 21 C.F.R. § 866.3200Echinococcus spp. serological reagents.
- 21 C.F.R. § 866.3205Echovirus serological reagents.
- 21 C.F.R. § 866.3210Endotoxin assay.
- 21 C.F.R. § 866.3215Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
- 21 C.F.R. § 866.3220Entamoeba histolytica serological reagents.
- 21 C.F.R. § 866.3225Enterovirus nucleic acid assay.
- 21 C.F.R. § 866.3230Device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections.
- 21 C.F.R. § 866.3231Device to detect bacterial protease activity in chronic wound fluid.
- 21 C.F.R. § 866.3235Epstein-Barr virus serological reagents.
- 21 C.F.R. § 866.3236Device to detect or measure nucleic acid from viruses associated with head and neck cancers.
- 21 C.F.R. § 866.3240Equine encephalomyelitis virus serological reagents.
- 21 C.F.R. § 866.3250Erysipelothrix rhusiopathiae serological reagents.
- 21 C.F.R. § 866.3255Escherichia coli serological reagents.
- 21 C.F.R. § 866.3270Flavobacterium spp. serological reagents.
- 21 C.F.R. § 866.3280Francisella tularensis serological reagents.
- 21 C.F.R. § 866.3290Gonococcal antibody test (GAT).
- 21 C.F.R. § 866.3300Haemophilus spp. serological reagents.
- 21 C.F.R. § 866.3305Herpes simplex virus serological assays.
- 21 C.F.R. § 866.3307Herpes simplex virus nucleic acid-based assay for central nervous system infections.
- 21 C.F.R. § 866.3309Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
- 21 C.F.R. § 866.3310Hepatitis A virus (HAV) serological assays.
- 21 C.F.R. § 866.3320Histoplasma capsulatum serological reagents.
- 21 C.F.R. § 866.3328Influenza virus antigen detection test system.
- 21 C.F.R. § 866.3330Influenza virus serological reagents.
- 21 C.F.R. § 866.3332Reagents for detection of specific novel influenza A viruses.
- 21 C.F.R. § 866.3336John Cunningham Virus serological reagents.
- 21 C.F.R. § 866.3340Klebsiella spp. serological reagents.
- 21 C.F.R. § 866.3350Leptospira spp. serological reagents.
- 21 C.F.R. § 866.3355Listeria spp. serological reagents.
- 21 C.F.R. § 866.3360Lymphocytic choriomeningitis virus serological reagents.
- 21 C.F.R. § 866.3361Mass spectrometer system for clinical use for the identification of microorganisms.
- 21 C.F.R. § 866.3365Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
- 21 C.F.R. § 866.3367Device to detect and identify microbial nucleic acids by FISH in clinical specimens.
- 21 C.F.R. § 866.3370Mycobacterium tuberculosis immunofluorescent reagents.
- 21 C.F.R. § 866.3372Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens.
- 21 C.F.R. § 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.
- 21 C.F.R. § 866.3375Mycoplasma spp. serological reagents.
- 21 C.F.R. § 866.3376Device to detect and identify fungal nucleic acids directly in respiratory specimens.
- 21 C.F.R. § 866.3378Clinical mass spectrometry microorganism identification and differentiation system.
- 21 C.F.R. § 866.3380Mumps virus serological reagents.
- 21 C.F.R. § 866.3390Neisseria spp. direct serological test reagents.
- 21 C.F.R. § 866.3393Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s).
- 21 C.F.R. § 866.3395Norovirus serological reagents.
- 21 C.F.R. § 866.3400Parainfluenza virus serological reagents.
- 21 C.F.R. § 866.3402Plasmodium species antigen detection assays.
- 21 C.F.R. § 866.3405Poliovirus serological reagents.
- 21 C.F.R. § 866.3410Proteus spp. (Weil-Felix) serological reagents.
- 21 C.F.R. § 866.3415Pseudomonas spp. serological reagents.
- 21 C.F.R. § 866.3460Rabiesvirus immunofluorescent reagents.
- 21 C.F.R. § 866.3470Reovirus serological reagents.
- 21 C.F.R. § 866.3480Respiratory syncytial virus serological reagents.
- 21 C.F.R. § 866.3490Rhinovirus serological reagents.
- 21 C.F.R. § 866.3500Rickettsia serological reagents.
- 21 C.F.R. § 866.3510Rubella virus serological reagents.
- 21 C.F.R. § 866.3520Rubeola (measles) virus serological reagents.
- 21 C.F.R. § 866.3550Salmonella spp. serological reagents.
- 21 C.F.R. § 866.3600Schistosoma spp. serological reagents.
- 21 C.F.R. § 866.3630Serratia spp. serological reagents.
- 21 C.F.R. § 866.3660Shigella spp. serological reagents.
- 21 C.F.R. § 866.3680Sporothrix schenckii serological reagents.
- 21 C.F.R. § 866.3700Staphylococcus aureus serological reagents.
- 21 C.F.R. § 866.3720Streptococcus spp. exoenzyme reagents.
- 21 C.F.R. § 866.3740Streptococcus spp. serological reagents.
- 21 C.F.R. § 866.3780Toxoplasma gondii serological reagents.
- 21 C.F.R. § 866.3820Treponema pallidum nontreponemal test reagents.
- 21 C.F.R. § 866.3830Treponema pallidum treponemal test reagents.
- 21 C.F.R. § 866.3850Trichinella spiralis serological reagents.
- 21 C.F.R. § 866.3860Trichomonas vaginalis nucleic acid assay.
- 21 C.F.R. § 866.3870Trypanosoma spp. serological reagents.
- 21 C.F.R. § 866.3900Varicella-zoster virus serological reagents.
- 21 C.F.R. § 866.3920Assayed quality control material for clinical microbiology assays.
- 21 C.F.R. § 866.3930Vibrio cholerae serological reagents.
- 21 C.F.R. § 866.3935Zika virus serological reagents.