Subpart B—Clinical Chemistry Test Systems

1. CFR
2. ›
3. Title 21
4. ›
5. Chapter I
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7. Part 862
8. ›
9. Subpart B

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 862.1020
  § 862.1020 Acid phosphatase (total or prostatic) test system.
• 862.1025
  § 862.1025 Adrenocorticotropic hormone (ACTH) test system.
• 862.1030
  § 862.1030 Alanine amino transferase (ALT/SGPT) test system.
• 862.1035
  § 862.1035 Albumin test system.
• 862.1040
  § 862.1040 Aldolase test system.
• 862.1045
  § 862.1045 Aldosterone test system.
• 862.1050
  § 862.1050 Alkaline phosphatase or isoenzymes test system.
• 862.1055
  § 862.1055 Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.
• 862.1060
  § 862.1060 Delta-aminolevulinic acid test system.
• 862.1065
  § 862.1065 Ammonia test system.
• 862.1070
  § 862.1070 Amylase test system.
• 862.1075
  § 862.1075 Androstenedione test system.
• 862.1080
  § 862.1080 Androsterone test system.
• 862.1085
  § 862.1085 Angiotensin I and renin test system.
• 862.1090
  § 862.1090 Angiotensin converting enzyme (A.C.E.) test system.
• 862.1092
  § 862.1092 Anti-mullerian hormone test system.
• 862.1093
  § 862.1093 Menopause test system.
• 862.1095
  § 862.1095 Ascorbic acid test system.
• 862.1100
  § 862.1100 Aspartate amino transferase (AST/SGOT) test system.
• 862.1110
  § 862.1110 Bilirubin (total or direct) test system.
• 862.1113
  § 862.1113 Bilirubin (total and unbound) in the neonate test system.
• 862.1115
  § 862.1115 Urinary bilirubin and its conjugates (nonquantitative) test system.
• 862.1117
  § 862.1117 B-type natriuretic peptide test system.
• 862.1118
  § 862.1118 Biotinidase test system.
• 862.1120
  § 862.1120 Blood gases (P_CO2, P_O2) and blood pH test system.
• 862.1130
  § 862.1130 Blood volume test system.
• 862.1135
  § 862.1135 C-peptides of proinsulin test system.
• 862.1140
  § 862.1140 Calcitonin test system.
• 862.1145
  § 862.1145 Calcium test system.
• 862.1150
  § 862.1150 Calibrator.
• 862.1155
  § 862.1155 Human chorionic gonadotropin (HCG) test system.
• 862.1160
  § 862.1160 Bicarbonate/carbon dioxide test system.
• 862.1163
  § 862.1163 Cardiac allograft gene expression profiling test system.
• 862.1164
  § 862.1164 Setmelanotide eligibility gene variant detection system.
• 862.1165
  § 862.1165 Catecholamines (total) test system.
• 862.1170
  § 862.1170 Chloride test system.
• 862.1175
  § 862.1175 Cholesterol (total) test system.
• 862.1177
  § 862.1177 Cholylglycine test system.
• 862.1180
  § 862.1180 Chymotrypsin test system.
• 862.1185
  § 862.1185 Compound S (11-deoxycortisol) test system.
• 862.1187
  § 862.1187 Conjugated sulfolithocholic acid (SLCG) test system.
• 862.1190
  § 862.1190 Copper test system.
• 862.1195
  § 862.1195 Corticoids test system.
• 862.1200
  § 862.1200 Corticosterone test system.
• 862.1205
  § 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
• 862.1210
  § 862.1210 Creatine test system.
• 862.1215
  § 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
• 862.1220
  § 862.1220 Acute kidney injury test system.
• 862.1225
  § 862.1225 Creatinine test system.
• 862.1230
  § 862.1230 Cyclic AMP test system.
• 862.1235
  § 862.1235 Cyclosporine test system.
• 862.1240
  § 862.1240 Cystine test system.
• 862.1245
  § 862.1245 Dehydroepiandrosterone (free and sulfate) test system.
• 862.1250
  § 862.1250 Desoxycorticosterone test system.
• 862.1255
  § 862.1255 2,3-Diphosphoglyceric acid test system.
• 862.1260
  § 862.1260 Estradiol test system.
• 862.1265
  § 862.1265 Estriol test system.
• 862.1270
  § 862.1270 Estrogens (total, in pregnancy) test system.
• 862.1275
  § 862.1275 Estrogens (total, nonpregnancy) test system.
• 862.1280
  § 862.1280 Estrone test system.
• 862.1285
  § 862.1285 Etiocholanolone test system.
• 862.1290
  § 862.1290 Fatty acids test system.
• 862.1295
  § 862.1295 Folic acid test system.
• 862.1300
  § 862.1300 Follicle-stimulating hormone test system.
• 862.1305
  § 862.1305 Formiminoglutamic acid (FIGLU) test system.
• 862.1310
  § 862.1310 Galactose test system.
• 862.1315
  § 862.1315 Galactose-1-phosphate uridyl transferase test system.
• 862.1320
  § 862.1320 Gastric acidity test system.
• 862.1325
  § 862.1325 Gastrin test system.
• 862.1330
  § 862.1330 Globulin test system.
• 862.1335
  § 862.1335 Glucagon test system.
• 862.1340
  § 862.1340 Urinary glucose (nonquantitative) test system.
• 862.1345
  § 862.1345 Glucose test system.
• 862.1350
  § 862.1350 Continuous glucose monitor secondary alarm system.
• 862.1355
  § 862.1355 Integrated continuous glucose monitoring system.
• 862.1356
  § 862.1356 Interoperable automated glycemic controller.
• 862.1358
  § 862.1358 Insulin therapy adjustment device.
• 862.1360
  § 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.
• 862.1365
  § 862.1365 Glutathione test system.
• 862.1370
  § 862.1370 Human growth hormone test system.
• 862.1373
  § 862.1373 Hemoglobin A1c test system.
• 862.1375
  § 862.1375 Histidine test system.
• 862.1377
  § 862.1377 Urinary homocystine (nonquantitative) test system.
• 862.1380
  § 862.1380 Hydroxybutyric dehydrogenase test system.
• 862.1385
  § 862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system.
• 862.1390
  § 862.1390 5-Hydroxyindole acetic acid/serotonin test system.
• 862.1395
  § 862.1395 17-Hydroxyprogesterone test system.
• 862.1400
  § 862.1400 Hydroxyproline test system.
• 862.1405
  § 862.1405 Immunoreactive insulin test system.
• 862.1410
  § 862.1410 Iron (non-heme) test system.
• 862.1415
  § 862.1415 Iron-binding capacity test system.
• 862.1420
  § 862.1420 Isocitric dehydrogenase test system.
• 862.1430
  § 862.1430 17-Ketosteroids test system.
• 862.1435
  § 862.1435 Ketones (nonquantitative) test system.
• 862.1440
  § 862.1440 Lactate dehydrogenase test system.
• 862.1445
  § 862.1445 Lactate dehydrogenase isoenzymes test system.
• 862.1450
  § 862.1450 Lactic acid test system.
• 862.1455
  § 862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system.
• 862.1460
  § 862.1460 Leucine aminopeptidase test system.
• 862.1465
  § 862.1465 Lipase test system.
• 862.1470
  § 862.1470 Lipid (total) test system.
• 862.1475
  § 862.1475 Lipoprotein test system.
• 862.1485
  § 862.1485 Luteinizing hormone test system.
• 862.1488
  § 862.1488 Lysosomal storage disorder newborn screening test system.
• 862.1490
  § 862.1490 Lysozyme (muramidase) test system.
• 862.1493
  § 862.1493 Breast milk macronutrients test system.
• 862.1495
  § 862.1495 Magnesium test system.
• 862.1500
  § 862.1500 Malic dehydrogenase test system.
• 862.1505
  § 862.1505 Mucopolysaccharides (nonquantitative) test system.
• 862.1506
  § 862.1506 Muscular dystrophy newborn screening test.
• 862.1509
  § 862.1509 Methylmalonic acid (nonquantitative) test system.
• 862.1510
  § 862.1510 Nitrite (nonquantitative) test system.
• 862.1515
  § 862.1515 Nitrogen (amino-nitrogen) test system.
• 862.1520
  § 862.1520 5′-Nucleotidase test system.
• 862.1530
  § 862.1530 Plasma oncometry test system.
• 862.1535
  § 862.1535 Ornithine carbamyl transferase test system.
• 862.1540
  § 862.1540 Osmolality test system.
• 862.1542
  § 862.1542 Oxalate test system.
• 862.1545
  § 862.1545 Parathyroid hormone test system.
• 862.1550
  § 862.1550 Urinary pH (nonquantitative) test system.
• 862.1555
  § 862.1555 Phenylalanine test system.
• 862.1560
  § 862.1560 Urinary phenylketones (nonquantitative) test system.
• 862.1565
  § 862.1565 6-Phosphogluconate dehydrogenase test system.
• 862.1570
  § 862.1570 Phosphohexose isomerase test system.
• 862.1575
  § 862.1575 Phospholipid test system.
• 862.1580
  § 862.1580 Phosphorus (inorganic) test system.
• 862.1585
  § 862.1585 Human placental lactogen test system.
• 862.1590
  § 862.1590 Porphobilinogen test system.
• 862.1595
  § 862.1595 Porphyrins test system.
• 862.1600
  § 862.1600 Potassium test system.
• 862.1605
  § 862.1605 Pregnanediol test system.
• 862.1610
  § 862.1610 Pregnanetriol test system.
• 862.1615
  § 862.1615 Pregnenolone test system.
• 862.1620
  § 862.1620 Progesterone test system.
• 862.1622
  § 862.1622 Prognostic test for assessment of liver related disease progression.
• 862.1625
  § 862.1625 Prolactin (lactogen) test system.
• 862.1630
  § 862.1630 Protein (fractionation) test system.
• 862.1635
  § 862.1635 Total protein test system.
• 862.1640
  § 862.1640 Protein-bound iodine test system.
• 862.1645
  § 862.1645 Urinary protein or albumin (nonquantitative) test system.
• 862.1650
  § 862.1650 Pyruvate kinase test system.
• 862.1655
  § 862.1655 Pyruvic acid test system.
• 862.1660
  § 862.1660 Quality control material (assayed and unassayed).
• 862.1665
  § 862.1665 Sodium test system.
• 862.1670
  § 862.1670 Sorbitol dehydrogenase test system.
• 862.1675
  § 862.1675 Blood specimen collection device.
• 862.1676
  § 862.1676 Blood collection device for cell-free nucleic acids.
• 862.1678
  § 862.1678 Tacrolimus test system.
• 862.1680
  § 862.1680 Testosterone test system.
• 862.1685
  § 862.1685 Thyroxine-binding globulin test system.
• 862.1690
  § 862.1690 Thyroid stimulating hormone test system.
• 862.1695
  § 862.1695 Free thyroxine test system.
• 862.1700
  § 862.1700 Total thyroxine test system.
• 862.1705
  § 862.1705 Triglyceride test system.
• 862.1710
  § 862.1710 Total triiodothyronine test system.
• 862.1715
  § 862.1715 Triiodothyronine uptake test system.
• 862.1720
  § 862.1720 Triose phosphate isomerase test system.
• 862.1725
  § 862.1725 Trypsin test system.
• 862.1730
  § 862.1730 Free tyrosine test system.
• 862.1770
  § 862.1770 Urea nitrogen test system.
• 862.1775
  § 862.1775 Uric acid test system.
• 862.1780
  § 862.1780 Urinary calculi (stones) test system.
• 862.1785
  § 862.1785 Urinary urobilinogen (nonquantitative) test system.
• 862.1790
  § 862.1790 Uroporphyrin test system.
• 862.1795
  § 862.1795 Vanilmandelic acid test system.
• 862.1805
  § 862.1805 Vitamin A test system.
• 862.1810
  § 862.1810 Vitamin B₁₂ test system.
• 862.1815
  § 862.1815 Vitamin E test system.
• 862.1820
  § 862.1820 Xylose test system.
• 862.1825
  § 862.1825 Vitamin D test system.
• 862.1840
  § 862.1840 Total 25-hydroxyvitamin D mass spectrometry test system.