Subpart B - CLINICAL CHEMISTRY TEST SYSTEMS

Section 862.1020 - Acid phosphatase (total or prostatic) test system
Section 862.1025 - Adrenocorticotropic hormone (ACTH) test system
Section 862.1030 - Alanine amino transferase (ALT/SGPT) test system
Section 862.1035 - Albumin test system
Section 862.1040 - Aldolase test system
Section 862.1045 - Aldosterone test system
Section 862.1050 - Alkaline phosphatase or isoenzymes test system
Section 862.1055 - Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry
Section 862.1060 - Delta-aminolevulinic acid test system
Section 862.1065 - Ammonia test system
Section 862.1070 - Amylase test system
Section 862.1075 - Androstenedione test system
Section 862.1080 - Androsterone test system
Section 862.1085 - Angiotensin I and renin test system
Section 862.1090 - Angiotensin converting enzyme (A.C.E.) test system
Section 862.1095 - Ascorbic acid test system
Section 862.1100 - Aspartate amino transferase (AST/SGOT) test system
Section 862.1110 - Bilirubin (total or direct) test system
Section 862.1113 - Bilirubin (total and unbound) in the neonate test system
Section 862.1115 - Urinary bilirubin and its conjugates (nonquantitative) test system
Section 862.1117 - B-type natriuretic peptide test system
Section 862.1118 - Biotinidase test system
Section 862.1120 - Blood gases (P[CO2], P[O2]) and blood pH test system
Section 862.1130 - Blood volume test system
Section 862.1135 - C-peptides of proinsulin test system
Section 862.1140 - Calcitonin test system
Section 862.1145 - Calcium test system
Section 862.1150 - Calibrator
Section 862.1155 - Human chorionic gonadotropin (HCG) test system
Section 862.1160 - Bicarbonate/carbon dioxide test system
Section 862.1163 - Cardiac allograft gene expression profiling test system
Section 862.1165 - Catecholamines (total) test system
Section 862.1170 - Chloride test system
Section 862.1175 - Cholesterol (total) test system
Section 862.1177 - Cholylglycine test system
Section 862.1180 - Chymotrypsin test system
Section 862.1185 - Compound S (11-deoxycortisol) test system
Section 862.1187 - Conjugated sulfolithocholic acid (SLCG) test system
Section 862.1190 - Copper test system
Section 862.1195 - Corticoids test system
Section 862.1200 - Corticosterone test system
Section 862.1205 - Cortisol (hydrocortisone and hydroxycorticosterone) test system
Section 862.1210 - Creatine test system
Section 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system
Section 862.1220 - Acute kidney injury test system
Section 862.1225 - Creatinine test system
Section 862.1230 - Cyclic AMP test system
Section 862.1235 - Cyclosporine test system
Section 862.1240 - Cystine test system
Section 862.1245 - Dehydroepiandrosterone (free and sulfate) test system
Section 862.1250 - Desoxycorticosterone test system
Section 862.1255 - 2,3-Diphosphoglyceric acid test system
Section 862.1260 - Estradiol test system
Section 862.1265 - Estriol test system
Section 862.1270 - Estrogens (total, in pregnancy) test system
Section 862.1275 - Estrogens (total, nonpregnancy) test system
Section 862.1280 - Estrone test system
Section 862.1285 - Etiocholanolone test system
Section 862.1290 - Fatty acids test system
Section 862.1295 - Folic acid test system
Section 862.1300 - Follicle-stimulating hormone test system
Section 862.1305 - Formiminoglutamic acid (FIGLU) test system
Section 862.1310 - Galactose test system
Section 862.1315 - Galactose-1-phosphate uridyl transferase test system
Section 862.1320 - Gastric acidity test system
Section 862.1325 - Gastrin test system
Section 862.1330 - Globulin test system
Section 862.1335 - Glucagon test system
Section 862.1340 - Urinary glucose (nonquantitative) test system
Section 862.1345 - Glucose test system
Section 862.1350 - Continuous glucose monitor secondary alarm system
Section 862.1355 - Integrated continuous glucose monitoring system
Section 862.1356 - Interoperable automated glycemic controller
Section 862.1358 - Insulin therapy adjustment device
Section 862.1360 - Gamma-glutamyl transpeptidase and isoenzymes test system
Section 862.1365 - Glutathione test system
Section 862.1370 - Human growth hormone test system
Section 862.1373 - Hemoglobin A1c test system
Section 862.1375 - Histidine test system
Section 862.1377 - Urinary homocystine (nonquantitative) test system
Section 862.1380 - Hydroxybutyric dehydrogenase test system
Section 862.1385 - 17-Hydroxycorticosteroids (17-ketogenic steroids) test system
Section 862.1390 - 5-Hydroxyindole acetic acid/serotonin test system
Section 862.1395 - 17-Hydroxyprogesterone test system
Section 862.1400 - Hydroxyproline test system
Section 862.1405 - Immunoreactive insulin test system
Section 862.1410 - Iron (non-heme) test system
Section 862.1415 - Iron-binding capacity test system
Section 862.1420 - Isocitric dehydrogenase test system
Section 862.1430 - 17-Ketosteroids test system
Section 862.1435 - Ketones (nonquantitative) test system
Section 862.1440 - Lactate dehydrogenase test system
Section 862.1445 - Lactate dehydrogenase isoenzymes test system
Section 862.1450 - Lactic acid test system
Section 862.1455 - Lecithin/sphingomyelin ratio in amniotic fluid test system
Section 862.1460 - Leucine aminopeptidase test system
Section 862.1465 - Lipase test system
Section 862.1470 - Lipid (total) test system
Section 862.1475 - Lipoprotein test system
Section 862.1485 - Luteinizing hormone test system
Section 862.1490 - Lysozyme (muramidase) test system
Section 862.1495 - Magnesium test system
Section 862.1500 - Malic dehydrogenase test system
Section 862.1505 - Mucopolysaccharides (nonquantitative) test system
Section 862.1509 - Methylmalonic acid (nonquantitative) test system
Section 862.1510 - Nitrite (nonquantitative) test system
Section 862.1515 - Nitrogen (amino-nitrogen) test system
Section 862.1520 - 5'-Nucleotidase test system
Section 862.1530 - Plasma oncometry test system
Section 862.1535 - Ornithine carbamyl transferase test system
Section 862.1540 - Osmolality test system
Section 862.1542 - Oxalate test system
Section 862.1545 - Parathyroid hormone test system
Section 862.1550 - Urinary pH (nonquantitative) test system
Section 862.1555 - Phenylalanine test system
Section 862.1560 - Urinary phenylketones (nonquantitative) test system
Section 862.1565 - 6-Phosphogluconate dehydrogenase test system
Section 862.1570 - Phosphohexose isomerase test system
Section 862.1575 - Phospholipid test system
Section 862.1580 - Phosphorus (inorganic) test system
Section 862.1585 - Human placental lactogen test system
Section 862.1590 - Porphobilinogen test system
Section 862.1595 - Porphyrins test system
Section 862.1600 - Potassium test system
Section 862.1605 - Pregnanediol test system
Section 862.1610 - Pregnanetriol test system
Section 862.1615 - Pregnenolone test system
Section 862.1620 - Progesterone test system
Section 862.1622 - Prognostic test for assessment of liver related disease progression
Section 862.1625 - Prolactin (lactogen) test system
Section 862.1630 - Protein (fractionation) test system
Section 862.1635 - Total protein test system
Section 862.1640 - Protein-bound iodine test system
Section 862.1645 - Urinary protein or albumin (nonquantitative) test system
Section 862.1650 - Pyruvate kinase test system
Section 862.1655 - Pyruvic acid test system
Section 862.1660 - Quality control material (assayed and unassayed)
Section 862.1665 - Sodium test system
Section 862.1670 - Sorbitol dehydrogenase test system
Section 862.1675 - Blood specimen collection device
Section 862.1678 - Tacrolimus test system
Section 862.1680 - Testosterone test system
Section 862.1685 - Thyroxine-binding globulin test system
Section 862.1690 - Thyroid stimulating hormone test system
Section 862.1695 - Free thyroxine test system
Section 862.1700 - Total thyroxine test system
Section 862.1705 - Triglyceride test system
Section 862.1710 - Total triiodothyronine test system
Section 862.1715 - Triiodothyronine uptake test system
Section 862.1720 - Triose phosphate isomerase test system
Section 862.1725 - Trypsin test system
Section 862.1730 - Free tyrosine test system
Section 862.1770 - Urea nitrogen test system
Section 862.1775 - Uric acid test system
Section 862.1780 - Urinary calculi (stones) test system
Section 862.1785 - Urinary urobilinogen (nonquantitative) test system
Section 862.1790 - Uroporphyrin test system
Section 862.1795 - Vanilmandelic acid test system
Section 862.1805 - Vitamin A test system
Section 862.1810 - Vitamin B[12] test system
Section 862.1815 - Vitamin E test system
Section 862.1820 - Xylose test system
Section 862.1825 - Vitamin D test system
Section 862.1840 - Total 25-hydroxyvitamin D mass spectrometry test system