Federal (United States) · Regulations
Subpart B
173 sections
173 sections
- 21 C.F.R. § 862.1020Acid phosphatase (total or prostatic) test system.
- 21 C.F.R. § 862.1025Adrenocorticotropic hormone (ACTH) test system.
- 21 C.F.R. § 862.1030Alanine amino transferase (ALT/SGPT) test system.
- 21 C.F.R. § 862.1035Albumin test system.
- 21 C.F.R. § 862.1040Aldolase test system.
- 21 C.F.R. § 862.1045Aldosterone test system.
- 21 C.F.R. § 862.1050Alkaline phosphatase or isoenzymes test system.
- 21 C.F.R. § 862.1055Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.
- 21 C.F.R. § 862.1060Delta-aminolevulinic acid test system.
- 21 C.F.R. § 862.1065Ammonia test system.
- 21 C.F.R. § 862.1070Amylase test system.
- 21 C.F.R. § 862.1075Androstenedione test system.
- 21 C.F.R. § 862.1080Androsterone test system.
- 21 C.F.R. § 862.1085Angiotensin I and renin test system.
- 21 C.F.R. § 862.1090Angiotensin converting enzyme (A.C.E.) test system.
- 21 C.F.R. § 862.1092Anti-mullerian hormone test system.
- 21 C.F.R. § 862.1093Menopause test system.
- 21 C.F.R. § 862.1095Ascorbic acid test system.
- 21 C.F.R. § 862.1100Aspartate amino transferase (AST/SGOT) test system.
- 21 C.F.R. § 862.1110Bilirubin (total or direct) test system.
- 21 C.F.R. § 862.1113Bilirubin (total and unbound) in the neonate test system.
- 21 C.F.R. § 862.1115Urinary bilirubin and its conjugates (nonquantitative) test system.
- 21 C.F.R. § 862.1117B-type natriuretic peptide test system.
- 21 C.F.R. § 862.1118Biotinidase test system.
- 21 C.F.R. § 862.1120Blood gases (P CO2 , P O2 ) and blood pH test system.
- 21 C.F.R. § 862.1130Blood volume test system.
- 21 C.F.R. § 862.1135C-peptides of proinsulin test system.
- 21 C.F.R. § 862.1140Calcitonin test system.
- 21 C.F.R. § 862.1145Calcium test system.
- 21 C.F.R. § 862.1150Calibrator.
- 21 C.F.R. § 862.1155Human chorionic gonadotropin (HCG) test system.
- 21 C.F.R. § 862.1160Bicarbonate/carbon dioxide test system.
- 21 C.F.R. § 862.1163Cardiac allograft gene expression profiling test system.
- 21 C.F.R. § 862.1164Setmelanotide eligibility gene variant detection system.
- 21 C.F.R. § 862.1165Catecholamines (total) test system.
- 21 C.F.R. § 862.1170Chloride test system.
- 21 C.F.R. § 862.1175Cholesterol (total) test system.
- 21 C.F.R. § 862.1177Cholylglycine test system.
- 21 C.F.R. § 862.1180Chymotrypsin test system.
- 21 C.F.R. § 862.1185Compound S (11-deoxycortisol) test system.
- 21 C.F.R. § 862.1187Conjugated sulfolithocholic acid (SLCG) test system.
- 21 C.F.R. § 862.1190Copper test system.
- 21 C.F.R. § 862.1195Corticoids test system.
- 21 C.F.R. § 862.1200Corticosterone test system.
- 21 C.F.R. § 862.1205Cortisol (hydrocortisone and hydroxycorticosterone) test system.
- 21 C.F.R. § 862.1210Creatine test system.
- 21 C.F.R. § 862.1215Creatine phosphokinase/creatine kinase or isoenzymes test system.
- 21 C.F.R. § 862.1220Acute kidney injury test system.
- 21 C.F.R. § 862.1223Prognostic test for assessment of chronic kidney disease progression.
- 21 C.F.R. § 862.1225Creatinine test system.
- 21 C.F.R. § 862.1230Cyclic AMP test system.
- 21 C.F.R. § 862.1235Cyclosporine test system.
- 21 C.F.R. § 862.1240Cystine test system.
- 21 C.F.R. § 862.1245Dehydroepiandrosterone (free and sulfate) test system.
- 21 C.F.R. § 862.1250Desoxycorticosterone test system.
- 21 C.F.R. § 862.12552,3-Diphosphoglyceric acid test system.
- 21 C.F.R. § 862.1260Estradiol test system.
- 21 C.F.R. § 862.1265Estriol test system.
- 21 C.F.R. § 862.1270Estrogens (total, in pregnancy) test system.
- 21 C.F.R. § 862.1275Estrogens (total, nonpregnancy) test system.
- 21 C.F.R. § 862.1280Estrone test system.
- 21 C.F.R. § 862.1285Etiocholanolone test system.
- 21 C.F.R. § 862.1290Fatty acids test system.
- 21 C.F.R. § 862.1295Folic acid test system.
- 21 C.F.R. § 862.1300Follicle-stimulating hormone test system.
- 21 C.F.R. § 862.1305Formiminoglutamic acid (FIGLU) test system.
- 21 C.F.R. § 862.1310Galactose test system.
- 21 C.F.R. § 862.1315Galactose-1-phosphate uridyl transferase test system.
- 21 C.F.R. § 862.1320Gastric acidity test system.
- 21 C.F.R. § 862.1325Gastrin test system.
- 21 C.F.R. § 862.1330Globulin test system.
- 21 C.F.R. § 862.1335Glucagon test system.
- 21 C.F.R. § 862.1340Urinary glucose (nonquantitative) test system.
- 21 C.F.R. § 862.1345Glucose test system.
- 21 C.F.R. § 862.1350Continuous glucose monitor secondary alarm system.
- 21 C.F.R. § 862.1355Integrated continuous glucose monitoring system.
- 21 C.F.R. § 862.1356Interoperable automated glycemic controller.
- 21 C.F.R. § 862.1358Insulin therapy adjustment device.
- 21 C.F.R. § 862.1360Gamma-glutamyl transpeptidase and isoenzymes test system.
- 21 C.F.R. § 862.1365Glutathione test system.
- 21 C.F.R. § 862.1370Human growth hormone test system.
- 21 C.F.R. § 862.1373Hemoglobin A1c test system.
- 21 C.F.R. § 862.1375Histidine test system.
- 21 C.F.R. § 862.1377Urinary homocystine (nonquantitative) test system.
- 21 C.F.R. § 862.1380Hydroxybutyric dehydrogenase test system.
- 21 C.F.R. § 862.138517-Hydroxycorticosteroids (17-ketogenic steroids) test system.
- 21 C.F.R. § 862.13905-Hydroxyindole acetic acid/serotonin test system.
- 21 C.F.R. § 862.139517-Hydroxyprogesterone test system.
- 21 C.F.R. § 862.1400Hydroxyproline test system.
- 21 C.F.R. § 862.1405Immunoreactive insulin test system.
- 21 C.F.R. § 862.1410Iron (non-heme) test system.
- 21 C.F.R. § 862.1415Iron-binding capacity test system.
- 21 C.F.R. § 862.1420Isocitric dehydrogenase test system.
- 21 C.F.R. § 862.143017-Ketosteroids test system.
- 21 C.F.R. § 862.1435Ketones (nonquantitative) test system.
- 21 C.F.R. § 862.1440Lactate dehydrogenase test system.
- 21 C.F.R. § 862.1445Lactate dehydrogenase isoenzymes test system.
- 21 C.F.R. § 862.1450Lactic acid test system.
- 21 C.F.R. § 862.1455Lecithin/sphingomyelin ratio in amniotic fluid test system.
- 21 C.F.R. § 862.1460Leucine aminopeptidase test system.