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Code of Federal Regulations

Subpart B

Clinical Chemistry Test Systems

862.1020Acid phosphatase (total or prostatic) test system.862.1025Adrenocorticotropic hormone (ACTH) test system.862.1030Alanine amino transferase (ALT/SGPT) test system.862.1035Albumin test system.862.1040Aldolase test system.862.1045Aldosterone test system.862.1050Alkaline phosphatase or isoenzymes test system.862.1055Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.862.1060Delta-aminolevulinic acid test system.862.1065Ammonia test system.862.1070Amylase test system.862.1075Androstenedione test system.862.1080Androsterone test system.862.1085Angiotensin I and renin test system.862.1090Angiotensin converting enzyme (A.C.E.) test system.862.1092Anti-mullerian hormone test system.862.1093Menopause test system.862.1095Ascorbic acid test system.862.1100Aspartate amino transferase (AST/SGOT) test system.862.1110Bilirubin (total or direct) test system.862.1113Bilirubin (total and unbound) in the neonate test system.862.1115Urinary bilirubin and its conjugates (nonquantitative) test system.862.1117B-type natriuretic peptide test system.862.1118Biotinidase test system.862.1120Blood gases (P 862.1130Blood volume test system.862.1135C-peptides of proinsulin test system.862.1140Calcitonin test system.862.1145Calcium test system.862.1150Calibrator.862.1155Human chorionic gonadotropin (HCG) test system.862.1160Bicarbonate/carbon dioxide test system.862.1163Cardiac allograft gene expression profiling test system.862.1164Setmelanotide eligibility gene variant detection system.862.1165Catecholamines (total) test system.862.1170Chloride test system.862.1175Cholesterol (total) test system.862.1177Cholylglycine test system.862.1180Chymotrypsin test system.862.1185Compound S (11-deoxycortisol) test system.862.1187Conjugated sulfolithocholic acid (SLCG) test system.862.1190Copper test system.862.1195Corticoids test system.862.1200Corticosterone test system.862.1205Cortisol (hydrocortisone and hydroxycorticosterone) test system.862.1210Creatine test system.862.1215Creatine phosphokinase/creatine kinase or isoenzymes test system.862.1220Acute kidney injury test system.862.1225Creatinine test system.862.1230Cyclic AMP test system.862.1235Cyclosporine test system.862.1240Cystine test system.862.1245Dehydroepiandrosterone (free and sulfate) test system.862.1250Desoxycorticosterone test system.862.12552,3-Diphosphoglyceric acid test system.862.1260Estradiol test system.862.1265Estriol test system.862.1270Estrogens (total, in pregnancy) test system.862.1275Estrogens (total, nonpregnancy) test system.862.1280Estrone test system.862.1285Etiocholanolone test system.862.1290Fatty acids test system.862.1295Folic acid test system.862.1300Follicle-stimulating hormone test system.862.1305Formiminoglutamic acid (FIGLU) test system.862.1310Galactose test system.862.1315Galactose-1-phosphate uridyl transferase test system.862.1320Gastric acidity test system.862.1325Gastrin test system.862.1330Globulin test system.862.1335Glucagon test system.862.1340Urinary glucose (nonquantitative) test system.862.1345Glucose test system.862.1350Continuous glucose monitor secondary alarm system.862.1355Integrated continuous glucose monitoring system.862.1356Interoperable automated glycemic controller.862.1358Insulin therapy adjustment device.862.1360Gamma-glutamyl transpeptidase and isoenzymes test system.862.1365Glutathione test system.862.1370Human growth hormone test system.862.1373Hemoglobin A1c test system.862.1375Histidine test system.862.1377Urinary homocystine (nonquantitative) test system.862.1380Hydroxybutyric dehydrogenase test system.862.138517-Hydroxycorticosteroids (17-ketogenic steroids) test system.862.13905-Hydroxyindole acetic acid/serotonin test system.862.139517-Hydroxyprogesterone test system.862.1400Hydroxyproline test system.862.1405Immunoreactive insulin test system.862.1410Iron (non-heme) test system.862.1415Iron-binding capacity test system.862.1420Isocitric dehydrogenase test system.862.143017-Ketosteroids test system.862.1435Ketones (nonquantitative) test system.862.1440Lactate dehydrogenase test system.862.1445Lactate dehydrogenase isoenzymes test system.862.1450Lactic acid test system.862.1455Lecithin/sphingomyelin ratio in amniotic fluid test system.862.1460Leucine aminopeptidase test system.862.1465Lipase test system.862.1470Lipid (total) test system.862.1475Lipoprotein test system.862.1485Luteinizing hormone test system.862.1488Lysosomal storage disorder newborn screening test system.862.1490Lysozyme (muramidase) test system.862.1493Breast milk macronutrients test system.862.1495Magnesium test system.862.1500Malic dehydrogenase test system.862.1505Mucopolysaccharides (nonquantitative) test system.862.1506Muscular dystrophy newborn screening test.862.1509Methylmalonic acid (nonquantitative) test system.862.1510Nitrite (nonquantitative) test system.862.1515Nitrogen (amino-nitrogen) test system.862.15205′-Nucleotidase test system.862.1530Plasma oncometry test system.862.1535Ornithine carbamyl transferase test system.862.1540Osmolality test system.862.1542Oxalate test system.862.1545Parathyroid hormone test system.862.1550Urinary pH (nonquantitative) test system.862.1555Phenylalanine test system.862.1560Urinary phenylketones (nonquantitative) test system.862.15656-Phosphogluconate dehydrogenase test system.862.1570Phosphohexose isomerase test system.862.1575Phospholipid test system.862.1580Phosphorus (inorganic) test system.862.1585Human placental lactogen test system.862.1590Porphobilinogen test system.862.1595Porphyrins test system.862.1600Potassium test system.862.1602Prognostic test for development or progression of preeclampsia.862.1605Pregnanediol test system.862.1610Pregnanetriol test system.862.1615Pregnenolone test system.862.1620Progesterone test system.862.1622Prognostic test for assessment of liver related disease progression.862.1625Prolactin (lactogen) test system.862.1630Protein (fractionation) test system.862.1635Total protein test system.862.1640Protein-bound iodine test system.862.1645Urinary protein or albumin (nonquantitative) test system.862.1650Pyruvate kinase test system.862.1655Pyruvic acid test system.862.1660Quality control material (assayed and unassayed).862.1665Sodium test system.862.1670Sorbitol dehydrogenase test system.862.1675Blood specimen collection device.862.1676Blood collection device for cell-free nucleic acids.862.1678Tacrolimus test system.862.1680Testosterone test system.862.1685Thyroxine-binding globulin test system.862.1690Thyroid stimulating hormone test system.862.1695Free thyroxine test system.862.1700Total thyroxine test system.862.1705Triglyceride test system.862.1710Total triiodothyronine test system.862.1715Triiodothyronine uptake test system.862.1720Triose phosphate isomerase test system.862.1725Trypsin test system.862.1730Free tyrosine test system.862.1770Urea nitrogen test system.862.1775Uric acid test system.862.1780Urinary calculi (stones) test system.862.1785Urinary urobilinogen (nonquantitative) test system.862.1790Uroporphyrin test system.862.1795Vanilmandelic acid test system.862.1805Vitamin A test system.862.1810Vitamin B 862.1815Vitamin E test system.862.1820Xylose test system.862.1825Vitamin D test system.862.1840Total 25-hydroxyvitamin D mass spectrometry test system.