21 CFR 866, 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 immunolog-ical 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 immunolog-ical test system.
- § 866.5220 — Cohn fraction II immunolog-ical 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 C 3b inactivator immunological test system.
- § 866.5270 — C-reactive protein immuno-logical test system.
- § 866.5320 — Properdin factor B immuno-logical test system.
- § 866.5330 — Factor XIII, A, S, immuno-logical test system.
- § 866.5340 — Ferritin immunological test system.
- § 866.5350 — Fibrinopeptide A immuno-logical test system.
- § 866.5360 — Cohn fraction IV immuno-logical test system.
- § 866.5370 — Cohn fraction V immuno-logical test system.
- § 866.5380 — Free secretory component immuno-logical test system.
- § 866.5400 — Alpha -globulin immuno-logical 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 immuno-logical test system.
- § 866.5590 — Lipoprotein X immunolog-ical 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 immuno-logical 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 erythema-tosus immunological test system.
- § 866.5860 — Total spinal fluid immuno-logical 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.
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.
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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.
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§ 351 - Adulterated drugs and devices
§ 360 - Registration of producers of drugs or devices
§ 360c - Classification of devices intended for human use
§ 360e - Premarket approval
§ 360j - General provisions respecting control of devices intended for human use
§ 371 - Regulations and hearings
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.