Browse Federal regulations
Read the original sections, or search by topic.
- 21 CFR 862.1117 · B-type natriuretic peptide test system.
- 21 CFR 862.1118 · Biotinidase test system.
- 21 CFR 862.1120 · Blood gases (PCO2, PO2) and blood pH test system.
- 21 CFR 862.1130 · Blood volume test system.
- 21 CFR 862.1135 · C-peptides of proinsulin test system.
- 21 CFR 862.1140 · Calcitonin test system.
- 21 CFR 862.1145 · Calcium test system.
- 21 CFR 862.1150 · Calibrator.
- 21 CFR 862.1155 · Human chorionic gonadotropin (HCG) test system.
- 21 CFR 862.1160 · Bicarbonate/carbon dioxide test system.
- 21 CFR 862.1163 · Cardiac allograft gene expression profiling test system.
- 21 CFR 862.1164 · Setmelanotide eligibility gene variant detection system.
- 21 CFR 862.1165 · Catecholamines (total) test system.
- 21 CFR 862.1170 · Chloride test system.
- 21 CFR 862.1175 · Cholesterol (total) test system.
- 21 CFR 862.1177 · Cholylglycine test system.
- 21 CFR 862.1180 · Chymotrypsin test system.
- 21 CFR 862.1185 · Compound S (11-deoxycortisol) test system.
- 21 CFR 862.1187 · Conjugated sulfolithocholic acid (SLCG) test system.
- 21 CFR 862.1190 · Copper test system.
- 21 CFR 862.1195 · Corticoids test system.
- 21 CFR 862.1200 · Corticosterone test system.
- 21 CFR 862.1205 · Cortisol (hydrocortisone and hydroxycorticosterone) test system.
- 21 CFR 862.1210 · Creatine test system.
- 21 CFR 862.1215 · Creatine phosphokinase/creatine kinase or isoenzymes test system.
- 21 CFR 862.1220 · Acute kidney injury test system.
- 21 CFR 862.1223 · Prognostic test for assessment of chronic kidney disease progression.
- 21 CFR 862.1225 · Creatinine test system.
- 21 CFR 862.1230 · Cyclic AMP test system.
- 21 CFR 862.1235 · Cyclosporine test system.
- 21 CFR 862.1240 · Cystine test system.
- 21 CFR 862.1245 · Dehydroepiandrosterone (free and sulfate) test system.
- 21 CFR 862.1250 · Desoxycorticosterone test system.
- 21 CFR 862.1255 · 2,3-Diphosphoglyceric acid test system.
- 21 CFR 862.1260 · Estradiol test system.
- 21 CFR 862.1265 · Estriol test system.
- 21 CFR 862.1270 · Estrogens (total, in pregnancy) test system.
- 21 CFR 862.1275 · Estrogens (total, nonpregnancy) test system.
- 21 CFR 862.1280 · Estrone test system.
- 21 CFR 862.1285 · Etiocholanolone test system.
- 21 CFR 862.1290 · Fatty acids test system.
- 21 CFR 862.1295 · Folic acid test system.
- 21 CFR 862.1300 · Follicle-stimulating hormone test system.
- 21 CFR 862.1305 · Formiminoglutamic acid (FIGLU) test system.
- 21 CFR 862.1310 · Galactose test system.
- 21 CFR 862.1315 · Galactose-1-phosphate uridyl transferase test system.
- 21 CFR 862.1320 · Gastric acidity test system.
- 21 CFR 862.1325 · Gastrin test system.
- 21 CFR 862.1330 · Globulin test system.
- 21 CFR 862.1335 · Glucagon test system.
- 21 CFR 862.1340 · Urinary glucose (nonquantitative) test system.
- 21 CFR 862.1345 · Glucose test system.
- 21 CFR 862.1350 · Continuous glucose monitor secondary alarm system.
- 21 CFR 862.1355 · Integrated continuous glucose monitoring system.
- 21 CFR 862.1356 · Interoperable automated glycemic controller.
- 21 CFR 862.1358 · Insulin therapy adjustment device.
- 21 CFR 862.1360 · Gamma-glutamyl transpeptidase and isoenzymes test system.
- 21 CFR 862.1365 · Glutathione test system.
- 21 CFR 862.1370 · Human growth hormone test system.
- 21 CFR 862.1373 · Hemoglobin A1c test system.
- 21 CFR 862.1375 · Histidine test system.
- 21 CFR 862.1377 · Urinary homocystine (nonquantitative) test system.
- 21 CFR 862.1380 · Hydroxybutyric dehydrogenase test system.
- 21 CFR 862.1385 · 17-Hydroxycorticosteroids (17-ketogenic steroids) test system.
- 21 CFR 862.1390 · 5-Hydroxyindole acetic acid/serotonin test system.
- 21 CFR 862.1395 · 17-Hydroxyprogesterone test system.
- 21 CFR 862.1400 · Hydroxyproline test system.
- 21 CFR 862.1405 · Immunoreactive insulin test system.
- 21 CFR 862.1410 · Iron (non-heme) test system.
- 21 CFR 862.1415 · Iron-binding capacity test system.
- 21 CFR 862.1420 · Isocitric dehydrogenase test system.
- 21 CFR 862.1430 · 17-Ketosteroids test system.
- 21 CFR 862.1435 · Ketones (nonquantitative) test system.
- 21 CFR 862.1440 · Lactate dehydrogenase test system.
- 21 CFR 862.1445 · Lactate dehydrogenase isoenzymes test system.
- 21 CFR 862.1450 · Lactic acid test system.
- 21 CFR 862.1455 · Lecithin/sphingomyelin ratio in amniotic fluid test system.
- 21 CFR 862.1460 · Leucine aminopeptidase test system.
- 21 CFR 862.1465 · Lipase test system.
- 21 CFR 862.1470 · Lipid (total) test system.
- 21 CFR 862.1475 · Lipoprotein test system.
- 21 CFR 862.1485 · Luteinizing hormone test system.
- 21 CFR 862.1488 · Lysosomal storage disorder newborn screening test system.
- 21 CFR 862.1490 · Lysozyme (muramidase) test system.
- 21 CFR 862.1493 · Breast milk macronutrients test system.
- 21 CFR 862.1495 · Magnesium test system.
- 21 CFR 862.1500 · Malic dehydrogenase test system.
- 21 CFR 862.1505 · Mucopolysaccharides (nonquantitative) test system.
- 21 CFR 862.1506 · Muscular dystrophy newborn screening test.
- 21 CFR 862.1509 · Methylmalonic acid (nonquantitative) test system.
- 21 CFR 862.1510 · Nitrite (nonquantitative) test system.
- 21 CFR 862.1515 · Nitrogen (amino-nitrogen) test system.
- 21 CFR 862.1520 · 5′-Nucleotidase test system.
- 21 CFR 862.1530 · Plasma oncometry test system.
- 21 CFR 862.1535 · Ornithine carbamyl transferase test system.
- 21 CFR 862.1540 · Osmolality test system.
- 21 CFR 862.1542 · Oxalate test system.
- 21 CFR 862.1545 · Parathyroid hormone test system.
- 21 CFR 862.1550 · Urinary pH (nonquantitative) test system.
- 21 CFR 862.1555 · Phenylalanine test system.