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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 (parts 800 to 898)
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PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
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SUBPART F—Immunological Test Systems (§866.5040 to §866.5910)
CFR
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SUBPART F—Immunological Test Systems (§866.5040 to §866.5910)
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.
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