21 CFR Subpart B
Clinical Chemistry Test Systems
June 25, 2020
§
862.1035
Albumin test system
§
862.1050
Alkaline phosphatase or isoenzymes test system
§
862.1040
Aldolase test system
§
862.1045
Aldosterone test system
§
862.1020
Acid phosphatase (total or prostatic) test system
§
862.1025
Adrenocorticotropic hormone (ACTH) test system
§
862.1030
Alanine amino transferase (ALT/SGPT) test system
§
862.1055
Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry
§
862.1060
Delta-aminolevulinic acid test system
§
862.1065
Ammonia test system
§
862.1070
Amylase test system
§
862.1075
Androstenedione test system
§
862.1080
Androsterone test system
§
862.1085
Angiotensin I and renin test system
§
862.1090
Angiotensin converting enzyme (A.C.E.) test system
§
862.1095
Ascorbic acid test system
§
862.1100
Aspartate amino transferase (AST/SGOT) test system
§
862.1110
Bilirubin (total or direct) test system
§
862.1113
Bilirubin (total and unbound) in the neonate test system
§
862.1115
Urinary bilirubin and its conjugates (nonquantitative) test system
§
862.1117
B-type natriuretic peptide test system
§
862.1118
Biotinidase test system
§
862.1120
Blood gases (PCO2, PO2) and blood pH test system
§
862.1130
Blood volume test system
§
862.1135
C-peptides of proinsulin test system
§
862.1140
Calcitonin test system
§
862.1145
Calcium test system
§
862.1150
Calibrator
§
862.1180
Chymotrypsin test system
§
862.1155
Human chorionic gonadotropin (HCG) test system
§
862.1160
Bicarbonate/carbon dioxide test system
§
862.1163
Cardiac allograft gene expression profiling test system
§
862.1165
Catecholamines (total) test system
§
862.1170
Chloride test system
§
862.1175
Cholesterol (total) test system
§
862.1177
Cholylglycine test system
§
862.1185
Compound S (11-deoxycortisol) test system
§
862.1187
Conjugated sulfolithocholic acid (SLCG) test system
§
862.1190
Copper test system
§
862.1195
Corticoids test system
§
862.1200
Corticosterone test system
§
862.1205
Cortisol (hydrocortisone and hydroxycorticosterone) test system
§
862.1210
Creatine test system
§
862.1377
Urinary homocystine (nonquantitative) test system
§
862.1215
Creatine phosphokinase/creatine kinase or isoenzymes test system
§
862.1220
Acute kidney injury test system
§
862.1225
Creatinine test system
§
862.1230
Cyclic AMP test system
§
862.1235
Cyclosporine test system
§
862.1240
Cystine test system
§
862.1245
Dehydroepiandrosterone (free and sulfate) test system
§
862.1250
Desoxycorticosterone test system
§
862.1255
2,3-Diphosphoglyceric acid test system
§
862.1260
Estradiol test system
§
862.1265
Estriol test system
§
862.1270
Estrogens (total, in pregnancy) test system
§
862.1275
Estrogens (total, nonpregnancy) test system
§
862.1280
Estrone test system
§
862.1285
Etiocholanolone test system
§
862.1290
Fatty acids test system
§
862.1295
Folic acid test system
§
862.1300
Follicle-stimulating hormone test system
§
862.1305
Formiminoglutamic acid (FIGLU) test system
§
862.1310
Galactose test system
§
862.1315
Galactose-1-phosphate uridyl transferase test system
§
862.1320
Gastric acidity test system
§
862.1325
Gastrin test system
§
862.1330
Globulin test system
§
862.1335
Glucagon test system
§
862.1340
Urinary glucose (nonquantitative) test system
§
862.1345
Glucose test system
§
862.1350
Continuous glucose monitor secondary display
§
862.1485
Luteinizing hormone test system
§
862.1358
Insulin therapy adjustment device
§
862.1360
Gamma-glutamyl transpeptidase and isoenzymes test system
§
862.1365
Glutathione test system
§
862.1370
Human growth hormone test system
§
862.1373
Hemoglobin A1c test system
§
862.1375
Histidine test system
§
862.1380
Hydroxybutyric dehydrogenase test system
§
862.1385
17-Hydroxycorticosteroids (17-ketogenic steroids) test system
§
862.1390
5-Hydroxyindole acetic acid/serotonin test system
§
862.1395
17-Hydroxyprogesterone test system
§
862.1400
Hydroxyproline test system
§
862.1405
Immunoreactive insulin test system
§
862.1555
Phenylalanine test system
§
862.1410
Iron (non-heme) test system
§
862.1415
Iron-binding capacity test system
§
862.1420
Isocitric dehydrogenase test system
§
862.1430
17-Ketosteroids test system
§
862.1435
Ketones (nonquantitative) test system
§
862.1440
Lactate dehydrogenase test system
§
862.1690
Thyroid stimulating hormone test system
§
862.1445
Lactate dehydrogenase isoenzymes test system
§
862.1450
Lactic acid test system
§
862.1455
Lecithin/sphingomyelin ratio in amniotic fluid test system
§
862.1460
Leucine aminopeptidase test system
§
862.1465
Lipase test system
§
862.1470
Lipid (total) test system
§
862.1475
Lipoprotein test system
§
862.1490
Lysozyme (muramidase) test system
§
862.1495
Magnesium test system
§
862.1500
Malic dehydrogenase test system
§
862.1505
Mucopolysaccharides (nonquantitative) test system
§
862.1509
Methylmalonic acid (nonquantitative) test system
§
862.1510
Nitrite (nonquantitative) test system
§
862.1515
Nitrogen (amino-nitrogen) test system
§
862.1520
5′-Nucleotidase test system
§
862.1530
Plasma oncometry test system
§
862.1535
Ornithine carbamyl transferase test system
§
862.1540
Osmolality test system
§
862.1542
Oxalate test system
§
862.1545
Parathyroid hormone test system
§
862.1550
Urinary pH (nonquantitative) test system
§
862.1560
Urinary phenylketones (nonquantitative) test system
§
862.1565
6-Phosphogluconate dehydrogenase test system
§
862.1570
Phosphohexose isomerase test system
§
862.1575
Phospholipid test system
§
862.1580
Phosphorus (inorganic) test system
§
862.1585
Human placental lactogen test system
§
862.1590
Porphobilinogen test system
§
862.1595
Porphyrins test system
§
862.1600
Potassium test system
§
862.1605
Pregnanediol test system
§
862.1610
Pregnanetriol test system
§
862.1615
Pregnenolone test system
§
862.1620
Progesterone test system
§
862.1625
Prolactin (lactogen) test system
§
862.1695
Free thyroxine test system
§
862.1630
Protein (fractionation) test system
§
862.1635
Total protein test system
§
862.1640
Protein-bound iodine test system
§
862.1645
Urinary protein or albumin (nonquantitative) test system
§
862.1650
Pyruvate kinase test system
§
862.1655
Pyruvic acid test system
§
862.1700
Total thyroxine test system
§
862.1660
Quality control material (assayed and unassayed)
§
862.1665
Sodium test system
§
862.1670
Sorbitol dehydrogenase test system
§
862.1675
Blood specimen collection device
§
862.1678
Tacrolimus test system
§
862.1680
Testosterone test system
§
862.1685
Thyroxine-binding globulin test system
§
862.1705
Triglyceride test system
§
862.1710
Total triiodothyronine test system
§
862.1715
Triiodothyronine uptake test system
§
862.1720
Triose phosphate isomerase test system
§
862.1725
Trypsin test system
§
862.1730
Free tyrosine test system
§
862.1770
Urea nitrogen test system
§
862.1775
Uric acid test system
§
862.1780
Urinary calculi (stones) test system
§
862.1785
Urinary urobilinogen (nonquantitative) test system
§
862.1790
Uroporphyrin test system
§
862.1795
Vanilmandelic acid test system
§
862.1805
Vitamin A test system
§
862.1810
Vitamin B12 test system
§
862.1815
Vitamin E test system
§
862.1820
Xylose test system
§
862.1825
Vitamin D test system
§
862.1840
Total 25-hydroxyvitamin D mass spectrometry test system
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