Title 21

PART 866 SUBPART F

Subpart F - Immunological Test Systems

21:8.0.1.1.20.6.1.1SECTION 866.5040
   866.5040 Albumin immunological test system.
21:8.0.1.1.20.6.1.2SECTION 866.5060
   866.5060 Prealbumin immunological test system.
21:8.0.1.1.20.6.1.3SECTION 866.5065
   866.5065 Human allotypic marker immunological test system.
21:8.0.1.1.20.6.1.4SECTION 866.5080
   866.5080 Alpha-1-antichymotrypsin immunological test system.
21:8.0.1.1.20.6.1.5SECTION 866.5090
   866.5090 Antimitochondrial antibody immunological test system.
21:8.0.1.1.20.6.1.6SECTION 866.5100
   866.5100 Antinuclear antibody immunological test system.
21:8.0.1.1.20.6.1.7SECTION 866.5110
   866.5110 Antiparietal antibody immunological test system.
21:8.0.1.1.20.6.1.8SECTION 866.5120
   866.5120 Antismooth muscle antibody immunological test system.
21:8.0.1.1.20.6.1.9SECTION 866.5130
   866.5130 Alpha-1-antitrypsin immunological test system.
21:8.0.1.1.20.6.1.10SECTION 866.5150
   866.5150 Bence-Jones proteins immunological test system.
21:8.0.1.1.20.6.1.11SECTION 866.5160
   866.5160 Beta-globulin immunological test system.
21:8.0.1.1.20.6.1.12SECTION 866.5170
   866.5170 Breast milk immunological test system.
21:8.0.1.1.20.6.1.13SECTION 866.5180
   866.5180 Fecal calprotectin immunological test system.
21:8.0.1.1.20.6.1.14SECTION 866.5200
   866.5200 Carbonic anhydrase B and C immunological test system.
21:8.0.1.1.20.6.1.15SECTION 866.5210
   866.5210 Ceruloplasmin immunological test system.
21:8.0.1.1.20.6.1.16SECTION 866.5220
   866.5220 Cohn fraction II immunological test system.
21:8.0.1.1.20.6.1.17SECTION 866.5230
   866.5230 Colostrum immunological test system.
21:8.0.1.1.20.6.1.18SECTION 866.5240
   866.5240 Complement components immunological test system.
21:8.0.1.1.20.6.1.19SECTION 866.5250
   866.5250 Complement C1 inhibitor (inactivator) immunological test system.
21:8.0.1.1.20.6.1.20SECTION 866.5260
   866.5260 Complement C3b inactivator immunological test system.
21:8.0.1.1.20.6.1.21SECTION 866.5270
   866.5270 C-reactive protein immunological test system.
21:8.0.1.1.20.6.1.22SECTION 866.5320
   866.5320 Properdin factor B immunological test system.
21:8.0.1.1.20.6.1.23SECTION 866.5330
   866.5330 Factor XIII, A, S, immunological test system.
21:8.0.1.1.20.6.1.24SECTION 866.5340
   866.5340 Ferritin immunological test system.
21:8.0.1.1.20.6.1.25SECTION 866.5350
   866.5350 Fibrinopeptide A immunological test system.
21:8.0.1.1.20.6.1.26SECTION 866.5360
   866.5360 Cohn fraction IV immunological test system.
21:8.0.1.1.20.6.1.27SECTION 866.5370
   866.5370 Cohn fraction V immunological test system.
21:8.0.1.1.20.6.1.28SECTION 866.5380
   866.5380 Free secretory component immunological test system.
21:8.0.1.1.20.6.1.29SECTION 866.5400
   866.5400 Alpha-globulin immunological test system.
21:8.0.1.1.20.6.1.30SECTION 866.5420
   866.5420 Alpha-1-glycoproteins immunological test system.
21:8.0.1.1.20.6.1.31SECTION 866.5425
   866.5425 Alpha-2-glycoproteins immunological test system.
21:8.0.1.1.20.6.1.32SECTION 866.5430
   866.5430 Beta-2-glycoprotein I immunological test system.
21:8.0.1.1.20.6.1.33SECTION 866.5440
   866.5440 Beta-2-glycoprotein III immunological test system.
21:8.0.1.1.20.6.1.34SECTION 866.5460
   866.5460 Haptoglobin immunological test system.
21:8.0.1.1.20.6.1.35SECTION 866.5470
   866.5470 Hemoglobin immunological test system.
21:8.0.1.1.20.6.1.36SECTION 866.5490
   866.5490 Hemopexin immunological test system.
21:8.0.1.1.20.6.1.37SECTION 866.5500
   866.5500 Hypersensitivity pneumonitis immunological test system.
21:8.0.1.1.20.6.1.38SECTION 866.5510
   866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
21:8.0.1.1.20.6.1.39SECTION 866.5520
   866.5520 Immunoglobulin G (Fab fragment specific) immunological test system.
21:8.0.1.1.20.6.1.40SECTION 866.5530
   866.5530 Immunoglobulin G (Fc fragment specific) immunological test system.
21:8.0.1.1.20.6.1.41SECTION 866.5540
   866.5540 Immunoglobulin G (Fd fragment specific) immunological test system.
21:8.0.1.1.20.6.1.42SECTION 866.5550
   866.5550 Immunoglobulin (light chain specific) immunological test system.
21:8.0.1.1.20.6.1.43SECTION 866.5560
   866.5560 Lactic dehydrogenase immunological test system.
21:8.0.1.1.20.6.1.44SECTION 866.5570
   866.5570 Lactoferrin immunological test system.
21:8.0.1.1.20.6.1.45SECTION 866.5580
   866.5580 Alpha-1-lipoprotein immunological test system.
21:8.0.1.1.20.6.1.46SECTION 866.5590
   866.5590 Lipoprotein X immunological test system.
21:8.0.1.1.20.6.1.47SECTION 866.5600
   866.5600 Low-density lipoprotein immunological test system.
21:8.0.1.1.20.6.1.48SECTION 866.5620
   866.5620 Alpha-2-macroglobulin immunological test system.
21:8.0.1.1.20.6.1.49SECTION 866.5630
   866.5630 Beta-2-microglobulin immunological test system.
21:8.0.1.1.20.6.1.50SECTION 866.5640
   866.5640 Infectious mononucleosis immunological test system.
21:8.0.1.1.20.6.1.51SECTION 866.5660
   866.5660 Multiple autoantibodies immunological test system.
21:8.0.1.1.20.6.1.52SECTION 866.5665
   866.5665 Aquaporin-4 autoantibody immunological test system.
21:8.0.1.1.20.6.1.53SECTION 866.5670
   866.5670 Zinc transporter 8 autoantibody immunological test system.
21:8.0.1.1.20.6.1.54SECTION 866.5680
   866.5680 Myoglobin immunological test system.
21:8.0.1.1.20.6.1.55SECTION 866.5700
   866.5700 Whole human plasma or serum immunological test system.
21:8.0.1.1.20.6.1.56SECTION 866.5715
   866.5715 Plasminogen immunological test system.
21:8.0.1.1.20.6.1.57SECTION 866.5735
   866.5735 Prothrombin immunological test system.
21:8.0.1.1.20.6.1.58SECTION 866.5750
   866.5750 Radioallergosorbent (RAST) immunological test system.
21:8.0.1.1.20.6.1.59SECTION 866.5760
   866.5760 Tryptase test system.
21:8.0.1.1.20.6.1.60SECTION 866.5765
   866.5765 Retinol-binding protein immunological test system.
21:8.0.1.1.20.6.1.61SECTION 866.5775
   866.5775 Rheumatoid factor immunological test system.
21:8.0.1.1.20.6.1.62SECTION 866.5785
   866.5785 Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems.
21:8.0.1.1.20.6.1.63SECTION 866.5800
   866.5800 Seminal fluid (sperm) immunological test system.
21:8.0.1.1.20.6.1.64SECTION 866.5820
   866.5820 Systemic lupus erythematosus immunological test system.
21:8.0.1.1.20.6.1.65SECTION 866.5830
   866.5830 Brain trauma assessment test.
21:8.0.1.1.20.6.1.66SECTION 866.5860
   866.5860 Total spinal fluid immunological test system.
21:8.0.1.1.20.6.1.67SECTION 866.5870
   866.5870 Thyroid autoantibody immunological test system.
21:8.0.1.1.20.6.1.68SECTION 866.5880
   866.5880 Transferrin immunological test system.
21:8.0.1.1.20.6.1.69SECTION 866.5890
   866.5890 Inter-alpha trypsin inhibitor immunological test system.
21:8.0.1.1.20.6.1.70SECTION 866.5900
   866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
21:8.0.1.1.20.6.1.71SECTION 866.5910
   866.5910 Quality control material for cystic fibrosis nucleic acid assays.
21:8.0.1.1.20.6.1.72SECTION 866.5930
   866.5930 Newborn screening test for severe combined immunodeficiency disorder (SCID).
21:8.0.1.1.20.6.1.73SECTION 866.5940
   866.5940 Autosomal recessive carrier screening gene mutation detection system.
21:8.0.1.1.20.6.1.74SECTION 866.5950
   866.5950 Genetic health risk assessment system.