Code of Federal Regulations · Subpart

Subpart B — Clinical Chemistry Test Systems

21 C.F.R. pt. 862, subpt. B

• § 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
• § 862.1035 Albumin Test System
• § 862.1040 Aldolase Test System
• § 862.1045 Aldosterone Test System
• § 862.1050 Alkaline Phosphatase Or Isoenzymes 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
• § 862.1092 Anti-mullerian Hormone Test System
• § 862.1093 Menopause 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
• § 862.1155 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
• § 862.1180 Chymotrypsin 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
• § 862.1215 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 Alarm System
• § 862.1355 Integrated Continuous Glucose Monitoring System
• § 862.1356 Interoperable Automated Glycemic Controller
• § 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
• § 862.1377 Urinary Homocystine (nonquantitative) 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
• § 862.1410 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
• § 862.1445 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
• § 862.1485 Luteinizing Hormone Test System
• § 862.1488 Lysosomal Storage Disorder Newborn Screening Test System
• § 862.1490 Lysozyme (muramidase) Test System
• § 862.1493 Breast Milk Macronutrients Test System
• § 862.1495 Magnesium Test System
• § 862.1500 Malic Dehydrogenase Test System
• § 862.1505 Mucopolysaccharides (nonquantitative) Test System
• § 862.1506 Muscular Dystrophy Newborn Screening Test
• § 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
• § 862.1555 Phenylalanine 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
• § 862.1622 Prognostic Test For Assessment Of Liver Related Disease Progression
• § 862.1625 Prolactin (lactogen) 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
• § 862.1660 Quality Control Material (assayed And Unassayed)
• § 862.1665 Sodium Test System
• § 862.1670 Sorbitol Dehydrogenase Test System
• § 862.1675 Blood Specimen Collection Device
• § 862.1676 Blood Collection Device For Cell-free Nucleic Acids
• § 862.1678 Tacrolimus Test System
• § 862.1680 Testosterone Test System
• § 862.1685 Thyroxine-binding Globulin Test System
• § 862.1690 Thyroid Stimulating Hormone Test System
• § 862.1695 Free Thyroxine Test System
• § 862.1700 Total Thyroxine 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