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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 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
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SUBPART B—Clinical Chemistry Test Systems (§862.1020 to §862.1825)
CFR
Title 1 - General Provisions
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Title 3 - The President
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Title 6 - Domestic Security
Title 7 - Agriculture
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Title 50 - Wildlife and Fisheries
SUBPART B—Clinical Chemistry Test Systems (§862.1020 to §862.1825)
862.1020—Acid phosphatase (total or prostatic) test system.
862.1025—Adrenocorticotropic hormone (ACTH) test system.
862.1030—Alanine amino transferase (ALT/SGPT) test system.
862.1035—Albumin test system.
862.1040—Aldolase test system.
862.1045—Aldosterone test system.
862.1050—Alkaline phosphatase or isoenzymes test system.
862.1055—Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.
862.1060—Delta-aminolevulinic acid test system.
862.1065—Ammonia test system.
862.1070—Amylase test system.
862.1075—Androstenedione test system.
862.1080—Androsterone test system.
862.1085—Angiotensin I and renin test system.
862.1090—Angiotensin converting enzyme (A.C.E.) test system.
862.1095—Ascorbic acid test system.
862.1100—Aspartate amino transferase (AST/SGOT) test system.
862.1110—Bilirubin (total or direct) test system.
862.1113—Bilirubin (total and unbound) in the neonate test system.
862.1115—Urinary bilirubin and its conjugates (nonquantitative) test system.
862.1117—B-type natriuretic peptide test system.
862.1118—Biotinidase test system.
862.1120—Blood gases (P CO 2, P O 2) and blood pH test system.
862.1130—Blood volume test system.
862.1135—C-peptides of proinsulin test system.
862.1140—Calcitonin test system.
862.1145—Calcium test system.
862.1150—Calibrator.
862.1155—Human chorionic gonadotropin (HCG) test system.
862.1160—Bicarbonate/carbon dioxide test system.
862.1163—Cardiac allograft gene expression profiling test system.
862.1165—Catecholamines (total) test system.
862.1170—Chloride test system.
862.1175—Cholesterol (total) test system.
862.1177—Cholylglycine test system.
862.1180—Chymotrypsin test system.
862.1185—Compound S (11-deoxycortisol) test system.
862.1187—Conjugated sulfolithocholic acid (SLCG) test system.
862.1190—Copper test system.
862.1195—Corticoids test system.
862.1200—Corticosterone test system.
862.1205—Cortisol (hydrocortisone and hydroxycorticosterone) test system.
862.1210—Creatine test system.
862.1215—Creatine phosphokinase/creatine kinase or isoenzymes test system.
862.1225—Creatinine test system.
862.1230—Cyclic AMP test system.
862.1235—Cyclosporine test system.
862.1240—Cystine test system.
862.1245—Dehydroepiandrosterone (free and sulfate) test system.
862.1250—Desoxycorticosterone test system.
862.1255—2,3-Diphosphoglyceric acid test system.
862.1260—Estradiol test system.
862.1265—Estriol test system.
862.1270—Estrogens (total, in pregnancy) test system.
862.1275—Estrogens (total, nonpregnancy) test system.
862.1280—Estrone test system.
862.1285—Etiocholanolone test system.
862.1290—Fatty acids test system.
862.1295—Folic acid test system.
862.1300—Follicle-stimulating hormone test system.
862.1305—Formiminoglutamic acid (FIGLU) test system.
862.1310—Galactose test system.
862.1315—Galactose-1-phosphate uridyl transferase test system.
862.1320—Gastric acidity test system.
862.1325—Gastrin test system.
862.1330—Globulin test system.
862.1335—Glucagon test system.
862.1340—Urinary glucose (nonquantitative) test system.
862.1345—Glucose test system.
862.1360—Gamma-glutamyl transpeptidase and isoenzymes test system.
862.1365—Glutathione test system.
862.1370—Human growth hormone test system.
862.1375—Histidine test system.
862.1377—Urinary homocystine (nonquantitative) test system.
862.1380—Hydroxybutyric dehydrogenase test system.
862.1385—17-Hydroxycorticosteroids (17-ketogenic steroids) test system.
862.1390—5-Hydroxyindole acetic acid/serotonin test system.
862.1395—17-Hydroxyprogesterone test system.
862.1400—Hydroxyproline test system.
862.1405—Immunoreactive insulin test system.
862.1410—Iron (non-heme) test system.
862.1415—Iron-binding capacity test system.
862.1420—Isocitric dehydrogenase test system.
862.1430—17-Ketosteroids test system.
862.1435—Ketones (nonquantitative) test system.
862.1440—Lactate dehydrogenase test system.
862.1445—Lactate dehydrogenase isoenzymes test system.
862.1450—Lactic acid test system.
862.1455—Lecithin/sphingomyelin ratio in amniotic fluid test system.
862.1460—Leucine aminopeptidase test system.
862.1465—Lipase test system.
862.1470—Lipid (total) test system.
862.1475—Lipoprotein test system.
862.1485—Luteinizing hormone test system.
862.1490—Lysozyme (muramidase) test system.
862.1495—Magnesium test system.
862.1500—Malic dehydrogenase test system.
862.1505—Mucopolysaccharides (nonquantitative) test system.
862.1509—Methylmalonic acid (nonquantitative) test system.
862.1510—Nitrite (nonquantitative) test system.
862.1515—Nitrogen (amino-nitrogen) test system.
862.1520—5′-Nucleotidase test system.
862.1530—Plasma oncometry test system.
862.1535—Ornithine carbamyl transferase test system.
862.1540—Osmolality test system.
862.1542—Oxalate test system.
862.1545—Parathyroid hormone test system.
862.1550—Urinary pH (nonquantitative) test system.
862.1555—Phenylalanine test system.
862.1560—Urinary phenylketones (nonquantitative) test system.
862.1565—6-Phosphogluconate dehydrogenase test system.
862.1570—Phosphohexose isomerase test system.
862.1575—Phospholipid test system.
862.1580—Phosphorus (inorganic) test system.
862.1585—Human placental lactogen test system.
862.1590—Porphobilinogen test system.
862.1595—Porphyrins test system.
862.1600—Potassium test system.
862.1605—Pregnanediol test system.
862.1610—Pregnanetriol test system.
862.1615—Pregnenolone test system.
862.1620—Progesterone test system.
862.1625—Prolactin (lactogen) test system.
862.1630—Protein (fractionation) test system.
862.1635—Total protein test system.
862.1640—Protein-bound iodine test system.
862.1645—Urinary protein or albumin (nonquantitative) test system.
862.1650—Pyruvate kinase test system.
862.1655—Pyruvic acid test system.
862.1660—Quality control material (assayed and unassayed).
862.1665—Sodium test system.
862.1670—Sorbitol dehydrogenase test system.
862.1675—Blood specimen collection device.
862.1678—Tacrolimus test system.
862.1680—Testosterone test system.
862.1685—Thyroxine-binding globulin test system.
862.1690—Thyroid stimulating hormone test system.
862.1695—Free thyroxine test system.
862.1700—Total thyroxine test system.
862.1705—Triglyceride test system.
862.1710—Total triiodothyronine test system.
862.1715—Triiodothyronine uptake test system.
862.1720—Triose phosphate isomerase test system.
862.1725—Trypsin test system.
862.1730—Free tyrosine test system.
862.1770—Urea nitrogen test system.
862.1775—Uric acid test system.
862.1780—Urinary calculi (stones) test system.
862.1785—Urinary urobilinogen (nonquantitative) test system.
862.1790—Uroporphyrin test system.
862.1795—Vanilmandelic acid test system.
862.1805—Vitamin A test system.
862.1810—Vitamin B12 test system.
862.1815—Vitamin E test system.
862.1820—Xylose test system.
862.1825—Vitamin D test system.
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