Title 21

PART 862 SUBPART B

Subpart B - Clinical Chemistry Test Systems

• 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
• 52 FR 16122, May 1, 1987, unless otherwise noted.

21:8.0.1.1.18.2.1.1	SECTION 862.1020	862.1020 Acid phosphatase (total or prostatic) test system.
21:8.0.1.1.18.2.1.2	SECTION 862.1025	862.1025 Adrenocorticotropic hormone (ACTH) test system.
21:8.0.1.1.18.2.1.3	SECTION 862.1030	862.1030 Alanine amino transferase (ALT/SGPT) test system.
21:8.0.1.1.18.2.1.4	SECTION 862.1035	862.1035 Albumin test system.
21:8.0.1.1.18.2.1.5	SECTION 862.1040	862.1040 Aldolase test system.
21:8.0.1.1.18.2.1.6	SECTION 862.1045	862.1045 Aldosterone test system.
21:8.0.1.1.18.2.1.7	SECTION 862.1050	862.1050 Alkaline phosphatase or isoenzymes test system.
21:8.0.1.1.18.2.1.8	SECTION 862.1055	862.1055 Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.
21:8.0.1.1.18.2.1.9	SECTION 862.1060	862.1060 Delta-aminolevulinic acid test system.
21:8.0.1.1.18.2.1.10	SECTION 862.1065	862.1065 Ammonia test system.
21:8.0.1.1.18.2.1.11	SECTION 862.1070	862.1070 Amylase test system.
21:8.0.1.1.18.2.1.12	SECTION 862.1075	862.1075 Androstenedione test system.
21:8.0.1.1.18.2.1.13	SECTION 862.1080	862.1080 Androsterone test system.
21:8.0.1.1.18.2.1.14	SECTION 862.1085	862.1085 Angiotensin I and renin test system.
21:8.0.1.1.18.2.1.15	SECTION 862.1090	862.1090 Angiotensin converting enzyme (A.C.E.) test system.
21:8.0.1.1.18.2.1.16	SECTION 862.1095	862.1095 Ascorbic acid test system.
21:8.0.1.1.18.2.1.17	SECTION 862.1100	862.1100 Aspartate amino transferase (AST/SGOT) test system.
21:8.0.1.1.18.2.1.18	SECTION 862.1110	862.1110 Bilirubin (total or direct) test system.
21:8.0.1.1.18.2.1.19	SECTION 862.1113	862.1113 Bilirubin (total and unbound) in the neonate test system.
21:8.0.1.1.18.2.1.20	SECTION 862.1115	862.1115 Urinary bilirubin and its conjugates (nonquantitative) test system.
21:8.0.1.1.18.2.1.21	SECTION 862.1117	862.1117 B-type natriuretic peptide test system.
21:8.0.1.1.18.2.1.22	SECTION 862.1118	862.1118 Biotinidase test system.
21:8.0.1.1.18.2.1.23	SECTION 862.1120	862.1120 Blood gases (PCO2, PO2) and blood pH test system.
21:8.0.1.1.18.2.1.24	SECTION 862.1130	862.1130 Blood volume test system.
21:8.0.1.1.18.2.1.25	SECTION 862.1135	862.1135 C-peptides of proinsulin test system.
21:8.0.1.1.18.2.1.26	SECTION 862.1140	862.1140 Calcitonin test system.
21:8.0.1.1.18.2.1.27	SECTION 862.1145	862.1145 Calcium test system.
21:8.0.1.1.18.2.1.28	SECTION 862.1150	862.1150 Calibrator.
21:8.0.1.1.18.2.1.29	SECTION 862.1155	862.1155 Human chorionic gonadotropin (HCG) test system.
21:8.0.1.1.18.2.1.30	SECTION 862.1160	862.1160 Bicarbonate/carbon dioxide test system.
21:8.0.1.1.18.2.1.31	SECTION 862.1163	862.1163 Cardiac allograft gene expression profiling test system.
21:8.0.1.1.18.2.1.32	SECTION 862.1165	862.1165 Catecholamines (total) test system.
21:8.0.1.1.18.2.1.33	SECTION 862.1170	862.1170 Chloride test system.
21:8.0.1.1.18.2.1.34	SECTION 862.1175	862.1175 Cholesterol (total) test system.
21:8.0.1.1.18.2.1.35	SECTION 862.1177	862.1177 Cholylglycine test system.
21:8.0.1.1.18.2.1.36	SECTION 862.1180	862.1180 Chymotrypsin test system.
21:8.0.1.1.18.2.1.37	SECTION 862.1185	862.1185 Compound S (11-deoxycortisol) test system.
21:8.0.1.1.18.2.1.38	SECTION 862.1187	862.1187 Conjugated sulfolithocholic acid (SLCG) test system.
21:8.0.1.1.18.2.1.39	SECTION 862.1190	862.1190 Copper test system.
21:8.0.1.1.18.2.1.40	SECTION 862.1195	862.1195 Corticoids test system.
21:8.0.1.1.18.2.1.41	SECTION 862.1200	862.1200 Corticosterone test system.
21:8.0.1.1.18.2.1.42	SECTION 862.1205	862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
21:8.0.1.1.18.2.1.43	SECTION 862.1210	862.1210 Creatine test system.
21:8.0.1.1.18.2.1.44	SECTION 862.1215	862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
21:8.0.1.1.18.2.1.45	SECTION 862.1220	862.1220 Acute kidney injury test system.
21:8.0.1.1.18.2.1.46	SECTION 862.1225	862.1225 Creatinine test system.
21:8.0.1.1.18.2.1.47	SECTION 862.1230	862.1230 Cyclic AMP test system.
21:8.0.1.1.18.2.1.48	SECTION 862.1235	862.1235 Cyclosporine test system.
21:8.0.1.1.18.2.1.49	SECTION 862.1240	862.1240 Cystine test system.
21:8.0.1.1.18.2.1.50	SECTION 862.1245	862.1245 Dehydroepiandrosterone (free and sulfate) test system.
21:8.0.1.1.18.2.1.51	SECTION 862.1250	862.1250 Desoxycorticosterone test system.
21:8.0.1.1.18.2.1.52	SECTION 862.1255	862.1255 2,3-Diphosphoglyceric acid test system.
21:8.0.1.1.18.2.1.53	SECTION 862.1260	862.1260 Estradiol test system.
21:8.0.1.1.18.2.1.54	SECTION 862.1265	862.1265 Estriol test system.
21:8.0.1.1.18.2.1.55	SECTION 862.1270	862.1270 Estrogens (total, in pregnancy) test system.
21:8.0.1.1.18.2.1.56	SECTION 862.1275	862.1275 Estrogens (total, nonpregnancy) test system.
21:8.0.1.1.18.2.1.57	SECTION 862.1280	862.1280 Estrone test system.
21:8.0.1.1.18.2.1.58	SECTION 862.1285	862.1285 Etiocholanolone test system.
21:8.0.1.1.18.2.1.59	SECTION 862.1290	862.1290 Fatty acids test system.
21:8.0.1.1.18.2.1.60	SECTION 862.1295	862.1295 Folic acid test system.
21:8.0.1.1.18.2.1.61	SECTION 862.1300	862.1300 Follicle-stimulating hormone test system.
21:8.0.1.1.18.2.1.62	SECTION 862.1305	862.1305 Formiminoglutamic acid (FIGLU) test system.
21:8.0.1.1.18.2.1.63	SECTION 862.1310	862.1310 Galactose test system.
21:8.0.1.1.18.2.1.64	SECTION 862.1315	862.1315 Galactose-1-phosphate uridyl transferase test system.
21:8.0.1.1.18.2.1.65	SECTION 862.1320	862.1320 Gastric acidity test system.
21:8.0.1.1.18.2.1.66	SECTION 862.1325	862.1325 Gastrin test system.
21:8.0.1.1.18.2.1.67	SECTION 862.1330	862.1330 Globulin test system.
21:8.0.1.1.18.2.1.68	SECTION 862.1335	862.1335 Glucagon test system.
21:8.0.1.1.18.2.1.69	SECTION 862.1340	862.1340 Urinary glucose (nonquantitative) test system.
21:8.0.1.1.18.2.1.70	SECTION 862.1345	862.1345 Glucose test system.
21:8.0.1.1.18.2.1.71	SECTION 862.1350	862.1350 Continuous glucose monitor secondary display.
21:8.0.1.1.18.2.1.72	SECTION 862.1358	862.1358 Insulin therapy adjustment device.
21:8.0.1.1.18.2.1.73	SECTION 862.1360	862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.
21:8.0.1.1.18.2.1.74	SECTION 862.1365	862.1365 Glutathione test system.
21:8.0.1.1.18.2.1.75	SECTION 862.1370	862.1370 Human growth hormone test system.
21:8.0.1.1.18.2.1.76	SECTION 862.1373	862.1373 Hemoglobin A1c test system.
21:8.0.1.1.18.2.1.77	SECTION 862.1375	862.1375 Histidine test system.
21:8.0.1.1.18.2.1.78	SECTION 862.1377	862.1377 Urinary homocystine (nonquantitative) test system.
21:8.0.1.1.18.2.1.79	SECTION 862.1380	862.1380 Hydroxybutyric dehydrogenase test system.
21:8.0.1.1.18.2.1.80	SECTION 862.1385	862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system.
21:8.0.1.1.18.2.1.81	SECTION 862.1390	862.1390 5-Hydroxyindole acetic acid/serotonin test system.
21:8.0.1.1.18.2.1.82	SECTION 862.1395	862.1395 17-Hydroxyprogesterone test system.
21:8.0.1.1.18.2.1.83	SECTION 862.1400	862.1400 Hydroxyproline test system.
21:8.0.1.1.18.2.1.84	SECTION 862.1405	862.1405 Immunoreactive insulin test system.
21:8.0.1.1.18.2.1.85	SECTION 862.1410	862.1410 Iron (non-heme) test system.
21:8.0.1.1.18.2.1.86	SECTION 862.1415	862.1415 Iron-binding capacity test system.
21:8.0.1.1.18.2.1.87	SECTION 862.1420	862.1420 Isocitric dehydrogenase test system.
21:8.0.1.1.18.2.1.88	SECTION 862.1430	862.1430 17-Ketosteroids test system.
21:8.0.1.1.18.2.1.89	SECTION 862.1435	862.1435 Ketones (nonquantitative) test system.
21:8.0.1.1.18.2.1.90	SECTION 862.1440	862.1440 Lactate dehydrogenase test system.
21:8.0.1.1.18.2.1.91	SECTION 862.1445	862.1445 Lactate dehydrogenase isoenzymes test system.
21:8.0.1.1.18.2.1.92	SECTION 862.1450	862.1450 Lactic acid test system.
21:8.0.1.1.18.2.1.93	SECTION 862.1455	862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system.
21:8.0.1.1.18.2.1.94	SECTION 862.1460	862.1460 Leucine aminopeptidase test system.
21:8.0.1.1.18.2.1.95	SECTION 862.1465	862.1465 Lipase test system.
21:8.0.1.1.18.2.1.96	SECTION 862.1470	862.1470 Lipid (total) test system.
21:8.0.1.1.18.2.1.97	SECTION 862.1475	862.1475 Lipoprotein test system.
21:8.0.1.1.18.2.1.98	SECTION 862.1485	862.1485 Luteinizing hormone test system.
21:8.0.1.1.18.2.1.99	SECTION 862.1490	862.1490 Lysozyme (muramidase) test system.
21:8.0.1.1.18.2.1.100	SECTION 862.1495	862.1495 Magnesium test system.
21:8.0.1.1.18.2.1.101	SECTION 862.1500	862.1500 Malic dehydrogenase test system.
21:8.0.1.1.18.2.1.102	SECTION 862.1505	862.1505 Mucopolysaccharides (nonquantitative) test system.
21:8.0.1.1.18.2.1.103	SECTION 862.1509	862.1509 Methylmalonic acid (nonquantitative) test system.
21:8.0.1.1.18.2.1.104	SECTION 862.1510	862.1510 Nitrite (nonquantitative) test system.
21:8.0.1.1.18.2.1.105	SECTION 862.1515	862.1515 Nitrogen (amino-nitrogen) test system.
21:8.0.1.1.18.2.1.106	SECTION 862.1520	862.1520 5′-Nucleotidase test system.
21:8.0.1.1.18.2.1.107	SECTION 862.1530	862.1530 Plasma oncometry test system.
21:8.0.1.1.18.2.1.108	SECTION 862.1535	862.1535 Ornithine carbamyl transferase test system.
21:8.0.1.1.18.2.1.109	SECTION 862.1540	862.1540 Osmolality test system.
21:8.0.1.1.18.2.1.110	SECTION 862.1542	862.1542 Oxalate test system.
21:8.0.1.1.18.2.1.111	SECTION 862.1545	862.1545 Parathyroid hormone test system.
21:8.0.1.1.18.2.1.112	SECTION 862.1550	862.1550 Urinary pH (nonquantitative) test system.
21:8.0.1.1.18.2.1.113	SECTION 862.1555	862.1555 Phenylalanine test system.
21:8.0.1.1.18.2.1.114	SECTION 862.1560	862.1560 Urinary phenylketones (nonquantitative) test system.
21:8.0.1.1.18.2.1.115	SECTION 862.1565	862.1565 6-Phosphogluconate dehydrogenase test system.
21:8.0.1.1.18.2.1.116	SECTION 862.1570	862.1570 Phosphohexose isomerase test system.
21:8.0.1.1.18.2.1.117	SECTION 862.1575	862.1575 Phospholipid test system.
21:8.0.1.1.18.2.1.118	SECTION 862.1580	862.1580 Phosphorus (inorganic) test system.
21:8.0.1.1.18.2.1.119	SECTION 862.1585	862.1585 Human placental lactogen test system.
21:8.0.1.1.18.2.1.120	SECTION 862.1590	862.1590 Porphobilinogen test system.
21:8.0.1.1.18.2.1.121	SECTION 862.1595	862.1595 Porphyrins test system.
21:8.0.1.1.18.2.1.122	SECTION 862.1600	862.1600 Potassium test system.
21:8.0.1.1.18.2.1.123	SECTION 862.1605	862.1605 Pregnanediol test system.
21:8.0.1.1.18.2.1.124	SECTION 862.1610	862.1610 Pregnanetriol test system.
21:8.0.1.1.18.2.1.125	SECTION 862.1615	862.1615 Pregnenolone test system.
21:8.0.1.1.18.2.1.126	SECTION 862.1620	862.1620 Progesterone test system.
21:8.0.1.1.18.2.1.127	SECTION 862.1625	862.1625 Prolactin (lactogen) test system.
21:8.0.1.1.18.2.1.128	SECTION 862.1630	862.1630 Protein (fractionation) test system.
21:8.0.1.1.18.2.1.129	SECTION 862.1635	862.1635 Total protein test system.
21:8.0.1.1.18.2.1.130	SECTION 862.1640	862.1640 Protein-bound iodine test system.
21:8.0.1.1.18.2.1.131	SECTION 862.1645	862.1645 Urinary protein or albumin (nonquantitative) test system.
21:8.0.1.1.18.2.1.132	SECTION 862.1650	862.1650 Pyruvate kinase test system.
21:8.0.1.1.18.2.1.133	SECTION 862.1655	862.1655 Pyruvic acid test system.
21:8.0.1.1.18.2.1.134	SECTION 862.1660	862.1660 Quality control material (assayed and unassayed).
21:8.0.1.1.18.2.1.135	SECTION 862.1665	862.1665 Sodium test system.
21:8.0.1.1.18.2.1.136	SECTION 862.1670	862.1670 Sorbitol dehydrogenase test system.
21:8.0.1.1.18.2.1.137	SECTION 862.1675	862.1675 Blood specimen collection device.
21:8.0.1.1.18.2.1.138	SECTION 862.1678	862.1678 Tacrolimus test system.
21:8.0.1.1.18.2.1.139	SECTION 862.1680	862.1680 Testosterone test system.
21:8.0.1.1.18.2.1.140	SECTION 862.1685	862.1685 Thyroxine-binding globulin test system.
21:8.0.1.1.18.2.1.141	SECTION 862.1690	862.1690 Thyroid stimulating hormone test system.
21:8.0.1.1.18.2.1.142	SECTION 862.1695	862.1695 Free thyroxine test system.
21:8.0.1.1.18.2.1.143	SECTION 862.1700	862.1700 Total thyroxine test system.
21:8.0.1.1.18.2.1.144	SECTION 862.1705	862.1705 Triglyceride test system.
21:8.0.1.1.18.2.1.145	SECTION 862.1710	862.1710 Total triiodothyronine test system.
21:8.0.1.1.18.2.1.146	SECTION 862.1715	862.1715 Triiodothyronine uptake test system.
21:8.0.1.1.18.2.1.147	SECTION 862.1720	862.1720 Triose phosphate isomerase test system.
21:8.0.1.1.18.2.1.148	SECTION 862.1725	862.1725 Trypsin test system.
21:8.0.1.1.18.2.1.149	SECTION 862.1730	862.1730 Free tyrosine test system.
21:8.0.1.1.18.2.1.150	SECTION 862.1770	862.1770 Urea nitrogen test system.
21:8.0.1.1.18.2.1.151	SECTION 862.1775	862.1775 Uric acid test system.
21:8.0.1.1.18.2.1.152	SECTION 862.1780	862.1780 Urinary calculi (stones) test system.
21:8.0.1.1.18.2.1.153	SECTION 862.1785	862.1785 Urinary urobilinogen (nonquantitative) test system.
21:8.0.1.1.18.2.1.154	SECTION 862.1790	862.1790 Uroporphyrin test system.
21:8.0.1.1.18.2.1.155	SECTION 862.1795	862.1795 Vanilmandelic acid test system.
21:8.0.1.1.18.2.1.156	SECTION 862.1805	862.1805 Vitamin A test system.
21:8.0.1.1.18.2.1.157	SECTION 862.1810	862.1810 Vitamin B12 test system.
21:8.0.1.1.18.2.1.158	SECTION 862.1815	862.1815 Vitamin E test system.
21:8.0.1.1.18.2.1.159	SECTION 862.1820	862.1820 Xylose test system.
21:8.0.1.1.18.2.1.160	SECTION 862.1825	862.1825 Vitamin D test system.
21:8.0.1.1.18.2.1.161	SECTION 862.1840	862.1840 Total 25-hydroxyvitamin D mass spectrometry test system.

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