Title 21

PART 862 SUBPART b

Subpart B - Clinical Chemistry Test Systems

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