• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-
New Search
Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 866IMMUNOLOGY 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.
   § 866.1700 - 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.
   § 866.2300 - 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 pathogenicNeisseriaspp.
   § 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.
   § 866.2850 - Automated zone reader.
   § 866.2900 - Microbiological specimen collection and transport device.

Subpart D--Serological Reagents
   § 866.3010 - Acinetobacter calcoaceticusserological reagents.
   § 866.3020 - Adenovirus serological reagents.
   § 866.3035 - Arizonaspp. serological reagents.
   § 866.3040 - Aspergillusspp. serological reagents.
   § 866.3050 - Beta-glucan serological assays.
   § 866.3060 - Blastomyces dermatitidisserological reagents.
   § 866.3065 - Bordetellaspp. serological reagents.
   § 866.3085 - Brucellaspp. serological reagents.
   § 866.3110 - Campylobacter fetusserological reagents.
   § 866.3120 - Chlamydia serological reagents.
   § 866.3125 - Citrobacterspp. serological reagents.
   § 866.3135 - Coccidioides immitisserological reagents.
   § 866.3140 - Corynebacteriumspp. serological reagents.
   § 866.3145 - Coxsackievirus serological reagents.
   § 866.3165 - Cryptococcus neoformansserological reagents.
   § 866.3175 - Cytomegalovirus serological reagents.
   § 866.3200 - Echinococcusspp. serological reagents.
   § 866.3205 - Echovirus serological reagents.
   § 866.3210 - Endotoxin assay.
   § 866.3220 - Entamoeba histolyticaserological reagents.
   § 866.3225 - Enterovirus nucleic acid assay.
   § 866.3235 - Epstein-Barr virus serological reagents.
   § 866.3240 - Equine encephalomyelitis virus serological reagents.
   § 866.3250 - Erysipelothrix rhusiopathiaeserological reagents.
   § 866.3255 - Escherichia coliserological reagents.
   § 866.3270 - Flavobacteriumspp. serological reagents.
   § 866.3280 - Francisella tularensisserological reagents.
   § 866.3290 - Gonococcal antibody test (GAT).
   § 866.3300 - Haemophilusspp. serological reagents.
   § 866.3305 - Herpes simplex virus serological assays.
   § 866.3310 - Hepatitis A virus (HAV) serological assays.
   § 866.3320 - Histoplasma capsulatumserological reagents.
   § 866.3330 - Influenza virus serological reagents.
   § 866.3332 - Reagents for detection of specific novel influenza A viruses.
   § 866.3340 - Klebsiellaspp. serological reagents.
   § 866.3350 - Leptospiraspp. serological reagents.
   § 866.3355 - Listeriaspp. serological reagents.
   § 866.3360 - Lymphocytic choriomeningitis virus serological reagents.
   § 866.3370 - Mycobacterium tuberculosisimmunofluorescent reagents.
   § 866.3375 - Mycoplasmaspp. serological reagents.
   § 866.3380 - Mumps virus serological reagents.
   § 866.3390 - Neisseriaspp. 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 - Proteusspp. (Weil-Felix) serological reagents.
   § 866.3415 - Pseudomonasspp. 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 - Salmonellaspp. serological reagents.
   § 866.3600 - Schistosomaspp. serological reagents.
   § 866.3630 - Serratiaspp. serological reagents.
   § 866.3660 - Shigellaspp. serological reagents.
   § 866.3680 - Sporothrix schenckiiserological reagents.
   § 866.3700 - Staphylococcus aureusserological reagents.
   § 866.3720 - Streptococcusspp. exoenzyme reagents.
   § 866.3740 - Streptococcusspp. serological reagents.
   § 866.3780 - Toxoplasma gondiiserological reagents.
   § 866.3820 - Treponema pallidumnontreponemal test reagents.
   § 866.3830 - Treponema pallidumtreponemal test reagents.
   § 866.3850 - Trichinella spiralisserological reagents.
   § 866.3870 - Trypanosomaspp. serological reagents.
   § 866.3900 - Varicella-zoster virus serological reagents.
   § 866.3930 - Vibrio choleraeserological reagents.
   § 866.3940 - West Nile virus serological reagents.
   § 866.3950 - In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.
   § 866.3980 - Respiratory viral panel multiplex nucleic acid 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 fluorescencein situhybridization (FISH) enumeration systems.
   § 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 C2inhibitor (inactivator) immunological test system.
   § 866.5260 - Complement C3binactivator 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.
   § 866.5680 - 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.
   § 866.5765 - 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.
   § 866.5860 - Total spinal fluid immunological test system.
   § 866.5870 - Thyroid autoantibody immunological test system.
   § 866.5880 - Transferrin immunological test system.
   § 866.5890 - Inter-alphatrypsin 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.

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.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.

-
-