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Title 21
PART 866 SUBPART F
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Volume 8
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Chapter I
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Subchapter H
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Part 866
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Subpart F
Subpart F - Immunological Test Systems
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
47 FR 50823, Nov. 9, 1982, unless otherwise noted.
21:8.0.1.1.20.6.1.1
SECTION 866.5040
866.5040 Albumin immunological test system.
21:8.0.1.1.20.6.1.2
SECTION 866.5060
866.5060 Prealbumin immunological test system.
21:8.0.1.1.20.6.1.3
SECTION 866.5065
866.5065 Human allotypic marker immunological test system.
21:8.0.1.1.20.6.1.4
SECTION 866.5080
866.5080 Alpha-1-antichymotrypsin immunological test system.
21:8.0.1.1.20.6.1.5
SECTION 866.5090
866.5090 Antimitochondrial antibody immunological test system.
21:8.0.1.1.20.6.1.6
SECTION 866.5100
866.5100 Antinuclear antibody immunological test system.
21:8.0.1.1.20.6.1.7
SECTION 866.5110
866.5110 Antiparietal antibody immunological test system.
21:8.0.1.1.20.6.1.8
SECTION 866.5120
866.5120 Antismooth muscle antibody immunological test system.
21:8.0.1.1.20.6.1.9
SECTION 866.5130
866.5130 Alpha-1-antitrypsin immunological test system.
21:8.0.1.1.20.6.1.10
SECTION 866.5150
866.5150 Bence-Jones proteins immunological test system.
21:8.0.1.1.20.6.1.11
SECTION 866.5160
866.5160 Beta-globulin immunological test system.
21:8.0.1.1.20.6.1.12
SECTION 866.5170
866.5170 Breast milk immunological test system.
21:8.0.1.1.20.6.1.13
SECTION 866.5180
866.5180 Fecal calprotectin immunological test system.
21:8.0.1.1.20.6.1.14
SECTION 866.5200
866.5200 Carbonic anhydrase B and C immunological test system.
21:8.0.1.1.20.6.1.15
SECTION 866.5210
866.5210 Ceruloplasmin immunological test system.
21:8.0.1.1.20.6.1.16
SECTION 866.5220
866.5220 Cohn fraction II immunological test system.
21:8.0.1.1.20.6.1.17
SECTION 866.5230
866.5230 Colostrum immunological test system.
21:8.0.1.1.20.6.1.18
SECTION 866.5240
866.5240 Complement components immunological test system.
21:8.0.1.1.20.6.1.19
SECTION 866.5250
866.5250 Complement C1 inhibitor (inactivator) immunological test system.
21:8.0.1.1.20.6.1.20
SECTION 866.5260
866.5260 Complement C3b inactivator immunological test system.
21:8.0.1.1.20.6.1.21
SECTION 866.5270
866.5270 C-reactive protein immunological test system.
21:8.0.1.1.20.6.1.22
SECTION 866.5320
866.5320 Properdin factor B immunological test system.
21:8.0.1.1.20.6.1.23
SECTION 866.5330
866.5330 Factor XIII, A, S, immunological test system.
21:8.0.1.1.20.6.1.24
SECTION 866.5340
866.5340 Ferritin immunological test system.
21:8.0.1.1.20.6.1.25
SECTION 866.5350
866.5350 Fibrinopeptide A immunological test system.
21:8.0.1.1.20.6.1.26
SECTION 866.5360
866.5360 Cohn fraction IV immunological test system.
21:8.0.1.1.20.6.1.27
SECTION 866.5370
866.5370 Cohn fraction V immunological test system.
21:8.0.1.1.20.6.1.28
SECTION 866.5380
866.5380 Free secretory component immunological test system.
21:8.0.1.1.20.6.1.29
SECTION 866.5400
866.5400 Alpha-globulin immunological test system.
21:8.0.1.1.20.6.1.30
SECTION 866.5420
866.5420 Alpha-1-glycoproteins immunological test system.
21:8.0.1.1.20.6.1.31
SECTION 866.5425
866.5425 Alpha-2-glycoproteins immunological test system.
21:8.0.1.1.20.6.1.32
SECTION 866.5430
866.5430 Beta-2-glycoprotein I immunological test system.
21:8.0.1.1.20.6.1.33
SECTION 866.5440
866.5440 Beta-2-glycoprotein III immunological test system.
21:8.0.1.1.20.6.1.34
SECTION 866.5460
866.5460 Haptoglobin immunological test system.
21:8.0.1.1.20.6.1.35
SECTION 866.5470
866.5470 Hemoglobin immunological test system.
21:8.0.1.1.20.6.1.36
SECTION 866.5490
866.5490 Hemopexin immunological test system.
21:8.0.1.1.20.6.1.37
SECTION 866.5500
866.5500 Hypersensitivity pneumonitis immunological test system.
21:8.0.1.1.20.6.1.38
SECTION 866.5510
866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
21:8.0.1.1.20.6.1.39
SECTION 866.5520
866.5520 Immunoglobulin G (Fab fragment specific) immunological test system.
21:8.0.1.1.20.6.1.40
SECTION 866.5530
866.5530 Immunoglobulin G (Fc fragment specific) immunological test system.
21:8.0.1.1.20.6.1.41
SECTION 866.5540
866.5540 Immunoglobulin G (Fd fragment specific) immunological test system.
21:8.0.1.1.20.6.1.42
SECTION 866.5550
866.5550 Immunoglobulin (light chain specific) immunological test system.
21:8.0.1.1.20.6.1.43
SECTION 866.5560
866.5560 Lactic dehydrogenase immunological test system.
21:8.0.1.1.20.6.1.44
SECTION 866.5570
866.5570 Lactoferrin immunological test system.
21:8.0.1.1.20.6.1.45
SECTION 866.5580
866.5580 Alpha-1-lipoprotein immunological test system.
21:8.0.1.1.20.6.1.46
SECTION 866.5590
866.5590 Lipoprotein X immunological test system.
21:8.0.1.1.20.6.1.47
SECTION 866.5600
866.5600 Low-density lipoprotein immunological test system.
21:8.0.1.1.20.6.1.48
SECTION 866.5620
866.5620 Alpha-2-macroglobulin immunological test system.
21:8.0.1.1.20.6.1.49
SECTION 866.5630
866.5630 Beta-2-microglobulin immunological test system.
21:8.0.1.1.20.6.1.50
SECTION 866.5640
866.5640 Infectious mononucleosis immunological test system.
21:8.0.1.1.20.6.1.51
SECTION 866.5660
866.5660 Multiple autoantibodies immunological test system.
21:8.0.1.1.20.6.1.52
SECTION 866.5665
866.5665 Aquaporin-4 autoantibody immunological test system.
21:8.0.1.1.20.6.1.53
SECTION 866.5670
866.5670 Zinc transporter 8 autoantibody immunological test system.
21:8.0.1.1.20.6.1.54
SECTION 866.5680
866.5680 Myoglobin immunological test system.
21:8.0.1.1.20.6.1.55
SECTION 866.5700
866.5700 Whole human plasma or serum immunological test system.
21:8.0.1.1.20.6.1.56
SECTION 866.5715
866.5715 Plasminogen immunological test system.
21:8.0.1.1.20.6.1.57
SECTION 866.5735
866.5735 Prothrombin immunological test system.
21:8.0.1.1.20.6.1.58
SECTION 866.5750
866.5750 Radioallergosorbent (RAST) immunological test system.
21:8.0.1.1.20.6.1.59
SECTION 866.5760
866.5760 Tryptase test system.
21:8.0.1.1.20.6.1.60
SECTION 866.5765
866.5765 Retinol-binding protein immunological test system.
21:8.0.1.1.20.6.1.61
SECTION 866.5775
866.5775 Rheumatoid factor immunological test system.
21:8.0.1.1.20.6.1.62
SECTION 866.5785
866.5785 Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems.
21:8.0.1.1.20.6.1.63
SECTION 866.5800
866.5800 Seminal fluid (sperm) immunological test system.
21:8.0.1.1.20.6.1.64
SECTION 866.5820
866.5820 Systemic lupus erythematosus immunological test system.
21:8.0.1.1.20.6.1.65
SECTION 866.5830
866.5830 Brain trauma assessment test.
21:8.0.1.1.20.6.1.66
SECTION 866.5860
866.5860 Total spinal fluid immunological test system.
21:8.0.1.1.20.6.1.67
SECTION 866.5870
866.5870 Thyroid autoantibody immunological test system.
21:8.0.1.1.20.6.1.68
SECTION 866.5880
866.5880 Transferrin immunological test system.
21:8.0.1.1.20.6.1.69
SECTION 866.5890
866.5890 Inter-alpha trypsin inhibitor immunological test system.
21:8.0.1.1.20.6.1.70
SECTION 866.5900
866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
21:8.0.1.1.20.6.1.71
SECTION 866.5910
866.5910 Quality control material for cystic fibrosis nucleic acid assays.
21:8.0.1.1.20.6.1.72
SECTION 866.5930
866.5930 Newborn screening test for severe combined immunodeficiency disorder (SCID).
21:8.0.1.1.20.6.1.73
SECTION 866.5940
866.5940 Autosomal recessive carrier screening gene mutation detection system.
21:8.0.1.1.20.6.1.74
SECTION 866.5950
866.5950 Genetic health risk assessment system.