21 CFR 866, 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.
- § 866.3340 — 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 immuno-fluorescent 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. exo-enzyme reagents.
- § 866.3740 — Streptococcus spp. serological reagents.
- § 866.3780 — Toxoplasma gondii serological reagents.
- § 866.3820 — Treponema pallidum non-treponemal test reagents.
- § 866.3830 — Treponema pallidum tre-ponemal 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.
Title 21 published on 2012-04-01
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-7757 RIN Docket No. FDA-2012-N-0165 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correction. Effective April 9, 2012. 21 CFR Part 866 In the Federal Register of March 9, 2012 (76 FR 14272), the Food and Drug Administration (FDA) classified norovirus serological reagents into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices. The document published with inadvertent errors in the Analysis of Impacts section. This document corrects those errors.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
§ 360c - Classification of devices intended for human use
§ 360e - Premarket approval
§ 360j - General provisions respecting control of devices intended for human use
Title 21 published on 2012-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 866 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-06826 RIN Docket No. FDA-2013-N-0011 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective March 26, 2013. 21 CFR Parts 814, 822, 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892 The Food and Drug Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-7757 RIN Docket No. FDA-2012-N-0165 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correction. Effective April 9, 2012. 21 CFR Part 866 In the Federal Register of March 9, 2012 (76 FR 14272), the Food and Drug Administration (FDA) classified norovirus serological reagents into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices. The document published with inadvertent errors in the Analysis of Impacts section. This document corrects those errors.