21 CFR Subpart B - Subpart B—Clinical Chemistry Test Systems

  1. § 862.1020 Acid phosphatase (total or prostatic) test system.
  2. § 862.1025 Adrenocorticotropic hormone (ACTH) test system.
  3. § 862.1030 Alanine amino transferase (ALT/SGPT) test system.
  4. § 862.1035 Albumin test system.
  5. § 862.1040 Aldolase test system.
  6. § 862.1045 Aldosterone test system.
  7. § 862.1050 Alkaline phosphatase or isoenzymes test system.
  8. § 862.1055 Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.
  9. § 862.1060 Delta-aminolevulinic acid test system.
  10. § 862.1065 Ammonia test system.
  11. § 862.1070 Amylase test system.
  12. § 862.1075 Androstenedione test system.
  13. § 862.1080 Androsterone test system.
  14. § 862.1085 Angiotensin I and renin test system.
  15. § 862.1090 Angiotensin converting enzyme (A.C.E.) test system.
  16. § 862.1095 Ascorbic acid test system.
  17. § 862.1100 Aspartate amino transferase (AST/SGOT) test system.
  18. § 862.1110 Bilirubin (total or direct) test system.
  19. § 862.1113 Bilirubin (total and unbound) in the neonate test system.
  20. § 862.1115 Urinary bilirubin and its conjugates (nonquantitative) test system.
  21. § 862.1117 B-type natriuretic peptide test system.
  22. § 862.1118 Biotinidase test system.
  23. § 862.1120 Blood gases (PCO2, PO2) and blood pH test system.
  24. § 862.1130 Blood volume test system.
  25. § 862.1135 C-peptides of proinsulin test system.
  26. § 862.1140 Calcitonin test system.
  27. § 862.1145 Calcium test system.
  28. § 862.1150 Calibrator.
  29. § 862.1155 Human chorionic gonadotropin (HCG) test system.
  30. § 862.1160 Bicarbonate/carbon dioxide test system.
  31. § 862.1163 Cardiac allograft gene expression profiling test system.
  32. § 862.1165 Catecholamines (total) test system.
  33. § 862.1170 Chloride test system.
  34. § 862.1175 Cholesterol (total) test system.
  35. § 862.1177 Cholylglycine test system.
  36. § 862.1180 Chymotrypsin test system.
  37. § 862.1185 Compound S (11-deoxycortisol) test system.
  38. § 862.1187 Conjugated sulfolithocholic acid (SLCG) test system.
  39. § 862.1190 Copper test system.
  40. § 862.1195 Corticoids test system.
  41. § 862.1200 Corticosterone test system.
  42. § 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
  43. § 862.1210 Creatine test system.
  44. § 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
  45. § 862.1220 Acute kidney injury test system.
  46. § 862.1225 Creatinine test system.
  47. § 862.1230 Cyclic AMP test system.
  48. § 862.1235 Cyclosporine test system.
  49. § 862.1240 Cystine test system.
  50. § 862.1245 Dehydroepiandrosterone (free and sulfate) test system.
  51. § 862.1250 Desoxycorticosterone test system.
  52. § 862.1255 2,3-Diphosphoglyceric acid test system.
  53. § 862.1260 Estradiol test system.
  54. § 862.1265 Estriol test system.
  55. § 862.1270 Estrogens (total, in pregnancy) test system.
  56. § 862.1275 Estrogens (total, nonpregnancy) test system.
  57. § 862.1280 Estrone test system.
  58. § 862.1285 Etiocholanolone test system.
  59. § 862.1290 Fatty acids test system.
  60. § 862.1295 Folic acid test system.
  61. § 862.1300 Follicle-stimulating hormone test system.
  62. § 862.1305 Formiminoglutamic acid (FIGLU) test system.
  63. § 862.1310 Galactose test system.
  64. § 862.1315 Galactose-1-phosphate uridyl transferase test system.
  65. § 862.1320 Gastric acidity test system.
  66. § 862.1325 Gastrin test system.
  67. § 862.1330 Globulin test system.
  68. § 862.1335 Glucagon test system.
  69. § 862.1340 Urinary glucose (nonquantitative) test system.
  70. § 862.1345 Glucose test system.
  71. § 862.1350 Continuous glucose monitor secondary alarm system.
  72. § 862.1355 Integrated continuous glucose monitoring system.
  73. § 862.1356 Interoperable automated glycemic controller.
  74. § 862.1358 Insulin therapy adjustment device.
  75. § 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.
  76. § 862.1365 Glutathione test system.
  77. § 862.1370 Human growth hormone test system.
  78. § 862.1373 Hemoglobin A1c test system.
  79. § 862.1375 Histidine test system.
  80. § 862.1377 Urinary homocystine (nonquantitative) test system.
  81. § 862.1380 Hydroxybutyric dehydrogenase test system.
  82. § 862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system.
  83. § 862.1390 5-Hydroxyindole acetic acid/serotonin test system.
  84. § 862.1395 17-Hydroxyprogesterone test system.
  85. § 862.1400 Hydroxyproline test system.
  86. § 862.1405 Immunoreactive insulin test system.
  87. § 862.1410 Iron (non-heme) test system.
  88. § 862.1415 Iron-binding capacity test system.
  89. § 862.1420 Isocitric dehydrogenase test system.
  90. § 862.1430 17-Ketosteroids test system.
  91. § 862.1435 Ketones (nonquantitative) test system.
  92. § 862.1440 Lactate dehydrogenase test system.
  93. § 862.1445 Lactate dehydrogenase isoenzymes test system.
  94. § 862.1450 Lactic acid test system.
  95. § 862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system.
  96. § 862.1460 Leucine aminopeptidase test system.
  97. § 862.1465 Lipase test system.
  98. § 862.1470 Lipid (total) test system.
  99. § 862.1475 Lipoprotein test system.
  100. § 862.1485 Luteinizing hormone test system.
  101. § 862.1490 Lysozyme (muramidase) test system.
  102. § 862.1495 Magnesium test system.
  103. § 862.1500 Malic dehydrogenase test system.
  104. § 862.1505 Mucopolysaccharides (nonquantitative) test system.
  105. § 862.1509 Methylmalonic acid (nonquantitative) test system.
  106. § 862.1510 Nitrite (nonquantitative) test system.
  107. § 862.1515 Nitrogen (amino-nitrogen) test system.
  108. § 862.1520 5′-Nucleotidase test system.
  109. § 862.1530 Plasma oncometry test system.
  110. § 862.1535 Ornithine carbamyl transferase test system.
  111. § 862.1540 Osmolality test system.
  112. § 862.1542 Oxalate test system.
  113. § 862.1545 Parathyroid hormone test system.
  114. § 862.1550 Urinary pH (nonquantitative) test system.
  115. § 862.1555 Phenylalanine test system.
  116. § 862.1560 Urinary phenylketones (nonquantitative) test system.
  117. § 862.1565 6-Phosphogluconate dehydrogenase test system.
  118. § 862.1570 Phosphohexose isomerase test system.
  119. § 862.1575 Phospholipid test system.
  120. § 862.1580 Phosphorus (inorganic) test system.
  121. § 862.1585 Human placental lactogen test system.
  122. § 862.1590 Porphobilinogen test system.
  123. § 862.1595 Porphyrins test system.
  124. § 862.1600 Potassium test system.
  125. § 862.1605 Pregnanediol test system.
  126. § 862.1610 Pregnanetriol test system.
  127. § 862.1615 Pregnenolone test system.
  128. § 862.1620 Progesterone test system.
  129. § 862.1622 Prognostic test for assessment of liver related disease progression.
  130. § 862.1625 Prolactin (lactogen) test system.
  131. § 862.1630 Protein (fractionation) test system.
  132. § 862.1635 Total protein test system.
  133. § 862.1640 Protein-bound iodine test system.
  134. § 862.1645 Urinary protein or albumin (nonquantitative) test system.
  135. § 862.1650 Pyruvate kinase test system.
  136. § 862.1655 Pyruvic acid test system.
  137. § 862.1660 Quality control material (assayed and unassayed).
  138. § 862.1665 Sodium test system.
  139. § 862.1670 Sorbitol dehydrogenase test system.
  140. § 862.1675 Blood specimen collection device.
  141. § 862.1678 Tacrolimus test system.
  142. § 862.1680 Testosterone test system.
  143. § 862.1685 Thyroxine-binding globulin test system.
  144. § 862.1690 Thyroid stimulating hormone test system.
  145. § 862.1695 Free thyroxine test system.
  146. § 862.1700 Total thyroxine test system.
  147. § 862.1705 Triglyceride test system.
  148. § 862.1710 Total triiodothyronine test system.
  149. § 862.1715 Triiodothyronine uptake test system.
  150. § 862.1720 Triose phosphate isomerase test system.
  151. § 862.1725 Trypsin test system.
  152. § 862.1730 Free tyrosine test system.
  153. § 862.1770 Urea nitrogen test system.
  154. § 862.1775 Uric acid test system.
  155. § 862.1780 Urinary calculi (stones) test system.
  156. § 862.1785 Urinary urobilinogen (nonquantitative) test system.
  157. § 862.1790 Uroporphyrin test system.
  158. § 862.1795 Vanilmandelic acid test system.
  159. § 862.1805 Vitamin A test system.
  160. § 862.1810 Vitamin B12 test system.
  161. § 862.1815 Vitamin E test system.
  162. § 862.1820 Xylose test system.
  163. § 862.1825 Vitamin D test system.
  164. § 862.1840 Total 25-hydroxyvitamin D mass spectrometry test system.