About GPO   |   Newsroom/Media   |   Congressional Relations   |   Inspector General   |   Careers   |   Contact   |   askGPO   |   Help  
 
Home   |   Customers   |   Vendors   |   Libraries  

The Electronic Code of Federal Regulations (e-CFR) is a regularly updated, unofficial editorial compilation of CFR material and Federal Register amendments produced by the National Archives and Records Administration's Office of the Federal Register (OFR) and the Government Printing Office.

Parallel Table of Authorities and Rules for the Code of Federal Regulations and the United States Code
Text | PDF

Find, review, and submit comments on Federal rules that are open for comment and published in the Federal Register using Regulations.gov.

Purchase individual CFR titles from the U.S. Government Online Bookstore.

Find issues of the CFR (including issues prior to 1996) at a local Federal depository library.

[2]
 
 

Electronic Code of Federal Regulations

blue pill

e-CFR Data is current as of April 21, 2014

TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES

rule

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).
rule

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.
rule

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 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.
§866.2850
Automated zone reader.
§866.2900
Microbiological specimen collection and transport device.
rule

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.
§866.3050
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.
§866.3135
Coccidioides immitis serological reagents.
§866.3140
Corynebacterium spp. serological reagents.
§866.3145
Coxsackievirus serological reagents.
§866.3165
Cryptococcus neoformans serological reagents.
§866.3175
Cytomegalovirus serological reagents.
§866.3200
Echinococcus spp. serological reagents.
§866.3205
Echovirus serological reagents.
§866.3210
Endotoxin assay.
§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.
§866.3310
Hepatitis A virus (HAV) serological assays.
§866.3320
Histoplasma capsulatum serological reagents.
§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.
§866.3370
Mycobacterium tuberculosis immunofluorescent reagents.
§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.
§866.3630
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.
§866.3870
Trypanosoma spp. serological reagents.
§866.3900
Varicella-zoster virus serological reagents.
§866.3930
Vibrio cholerae serological 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.
rule

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.
§866.4800
Radial immunodiffusion plate.
§866.4830
Rocket immunoelectrophoresis equipment.
§866.4900
Support gel.
rule

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 C2 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.
§866.5680
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-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.
rule

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.


For questions or comments regarding e-CFR editorial content, features, or design, email ecfr@nara.gov.
For questions concerning e-CFR programming and delivery issues, email webteam@gpo.gov.