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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 866 - Immunology and Microbiology Devices |
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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 C1 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. |
| § 866.5665 - Aquaporin-4 autoantibody immunological test system. |
| § 866.5670 - Zinc transporter 8 autoantibody 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. |
| § 866.5760 - Tryptase 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. |
| § 866.5830 - Brain trauma assessment test. |
| § 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. |
| § 866.5930 - Newborn screening test for severe combined immunodeficiency disorder (SCID). |
| § 866.5940 - Autosomal recessive carrier screening gene mutation detection system. |
| § 866.5950 - Genetic health risk assessment system. |
| § 866.5960 - Human leukocyte antigen typing companion diagnostic test. |