21 CFR Subpart F
Immunological Test Systems
June 25, 2020
§
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
§
866.5400
Alpha-globulin 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
§
866.5420
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
§
866.5715
Plasminogen 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
§
866.5735
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
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