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Part 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

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MEDICAL DEVICES - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

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Part 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

Description

Official eCFR Link

§862.1 - Scope.

§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.

§862.1095 - 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 (P

§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 display.

§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.