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Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
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 | 862.1 | Scope. |
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| 862.2 | Regulation of calibrators. |
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| 862.3 | Effective dates of requirement for premarket approval. |
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| 862.9 | Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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| 862.1020 | Acid phosphatase (total or prostatic) test system. |
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| 862.1025 | Adrenocorticotropic hormone (ACTH) test system. |
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| 862.1030 | Alanine amino transferase (ALT/SGPT) test system. |
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| 862.1035 | Albumin test system. |
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| 862.1040 | Aldolase test system. |
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| 862.1045 | Aldosterone test system. |
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| 862.1050 | Alkaline phosphatase or isoenzymes test system. |
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| 862.1055 | Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry. |
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| 862.1060 | Delta-aminolevulinic acid test system. |
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| 862.1065 | Ammonia test system. |
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| 862.1070 | Amylase test system. |
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| 862.1075 | Androstenedione test system. |
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| 862.1080 | Androsterone test system. |
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| 862.1085 | Angiotensin I and renin test system. |
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| 862.1090 | Angiotensin converting enzyme (A.C.E.) test system. |
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| 862.1095 | Ascorbic acid test system. |
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| 862.1100 | Aspartate amino transferase (AST/SGOT) test system. |
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| 862.1110 | Bilirubin (total or direct) test system. |
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| 862.1113 | Bilirubin (total and unbound) in the neonate test system. |
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| 862.1115 | Urinary bilirubin and its conjugates (nonquantitative) test system. |
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| 862.1117 | B-type natriuretic peptide test system. |
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| 862.1118 | Biotinidase test system. |
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| 862.1120 | Blood gases (PCO2, PO2) and blood pH test system. |
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| 862.1130 | Blood volume test system. |
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| 862.1135 | C-peptides of proinsulin test system. |
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| 862.1140 | Calcitonin test system. |
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| 862.1145 | Calcium test system. |
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| 862.1150 | Calibrator. |
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| 862.1155 | Human chorionic gonadotropin (HCG) test system. |
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| 862.1160 | Bicarbonate/carbon dioxide test system. |
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| 862.1165 | Catecholamines (total) test system. |
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| 862.1170 | Chloride test system. |
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| 862.1175 | Cholesterol (total) test system. |
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| 862.1177 | Cholylglycine test system. |
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| 862.1180 | Chymotrypsin test system. |
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| 862.1185 | Compound S (11-deoxycortisol) test system. |
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| 862.1187 | Conjugated sulfolithocholic acid (SLCG) test system. |
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| 862.1190 | Copper test system. |
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| 862.1195 | Corticoids test system. |
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| 862.1200 | Corticosterone test system. |
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| 862.1205 | Cortisol (hydrocortisone and hydroxycorticosterone) test system. |
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| 862.1210 | Creatine test system. |
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| 862.1215 | Creatine phosphokinase/creatine kinase or isoenzymes test system. |
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| 862.1225 | Creatinine test system. |
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| 862.1230 | Cyclic AMP test system. |
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| 862.1235 | Cyclosporine test system. |
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| 862.1240 | Cystine test system. |
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| 862.1245 | Dehydroepiandrosterone (free and sulfate) test system. |
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| 862.1250 | Desoxycorticosterone test system. |
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| 862.1255 | 2,3-Diphosphoglyceric acid test system. |
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| 862.1260 | Estradiol test system. |
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| 862.1265 | Estriol test system. |
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| 862.1270 | Estrogens (total, in pregnancy) test system. |
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| 862.1275 | Estrogens (total, nonpregnancy) test system. |
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| 862.1280 | Estrone test system. |
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| 862.1285 | Etiocholanolone test system. |
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| 862.1290 | Fatty acids test system. |
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| 862.1295 | Folic acid test system. |
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| 862.1300 | Follicle-stimulating hormone test system. |
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| 862.1305 | Formiminoglutamic acid (FIGLU) test system. |
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| 862.1310 | Galactose test system. |
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| 862.1315 | Galactose-1-phosphate uridyl transferase test system. |
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| 862.1320 | Gastric acidity test system. |
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| 862.1325 | Gastrin test system. |
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| 862.1330 | Globulin test system. |
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| 862.1335 | Glucagon test system. |
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| 862.1340 | Urinary glucose (nonquantitative) test system. |
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| 862.1345 | Glucose test system. |
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| 862.1360 | Gamma-glutamyl transpeptidase and isoenzymes test system. |
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| 862.1365 | Glutathione test system. |
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| 862.1370 | Human growth hormone test system. |
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| 862.1375 | Histidine test system. |
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| 862.1377 | Urinary homocystine (nonquantitative) test system. |
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| 862.1380 | Hydroxybutyric dehydrogenase test system. |
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| 862.1385 | 17-Hydroxycorticosteroids (17-ketogenic steroids) test system. |
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| 862.1390 | 5-Hydroxyindole acetic acid/serotonin test system. |
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| 862.1395 | 17-Hydroxyprogesterone test system. |
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| 862.1400 | Hydroxyproline test system. |
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| 862.1405 | Immunoreactive insulin test system. |
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| 862.1410 | Iron (non-heme) test system. |
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| 862.1415 | Iron-binding capacity test system. |
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| 862.1420 | Isocitric dehydrogenase test system. |
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| 862.1430 | 17-Ketosteroids test system. |
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| 862.1435 | Ketones (nonquantitative) test system. |
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| 862.1440 | Lactate dehydrogenase test system. |
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| 862.1445 | Lactate dehydrogenase isoenzymes test system. |
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| 862.1450 | Lactic acid test system. |
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| 862.1455 | Lecithin/sphingomyelin ratio in amniotic fluid test system. |
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| 862.1460 | Leucine aminopeptidase test system. |
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| 862.1465 | Lipase test system. |
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| 862.1470 | Lipid (total) test system. |
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| 862.1475 | Lipoprotein test system. |
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| 862.1485 | Luteinizing hormone test system. |
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| 862.1490 | Lysozyme (muramidase) test system. |
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| 862.1495 | Magnesium test system. |
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| 862.1500 | Malic dehydrogenase test system. |
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| 862.1505 | Mucopolysaccharides (nonquantitative) test system. |
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| 862.1509 | Methylmalonic acid (nonquantitative) test system. |
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| 862.1510 | Nitrite (nonquantitative) test system. |
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| 862.1515 | Nitrogen (amino-nitrogen) test system. |
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| 862.1520 | 5′-Nucleotidase test system. |
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| 862.1530 | Plasma oncometry test system. |
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| 862.1535 | Ornithine carbamyl transferase test system. |
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| 862.1540 | Osmolality test system. |
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| 862.1542 | Oxalate test system. |
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| 862.1545 | Parathyroid hormone test system. |
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| 862.1550 | Urinary pH (nonquantitative) test system. |
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| 862.1555 | Phenylalanine test system. |
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| 862.1560 | Urinary phenylketones (nonquantitative) test system. |
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| 862.1565 | 6-Phosphogluconate dehydrogenase test system. |
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| 862.1570 | Phosphohexose isomerase test system. |
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| 862.1575 | Phospholipid test system. |
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| 862.1580 | Phosphorus (inorganic) test system. |
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| 862.1585 | Human placental lactogen test system. |
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| 862.1590 | Porphobilinogen test system. |
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| 862.1595 | Porphyrins test system. |
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| 862.1600 | Potassium test system. |
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| 862.1605 | Pregnanediol test system. |
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| 862.1610 | Pregnanetriol test system. |
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| 862.1615 | Pregnenolone test system. |
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| 862.1620 | Progesterone test system. |
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| 862.1625 | Prolactin (lactogen) test system. |
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| 862.1630 | Protein (fractionation) test system. |
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| 862.1635 | Total protein test system. |
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| 862.1640 | Protein-bound iodine test system. |
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| 862.1645 | Urinary protein or albumin (nonquantitative) test system. |
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| 862.1650 | Pyruvate kinase test system. |
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| 862.1655 | Pyruvic acid test system. |
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| 862.1660 | Quality control material (assayed and unassayed). |
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| 862.1665 | Sodium test system. |
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| 862.1670 | Sorbitol dehydrogenase test system. |
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| 862.1675 | Blood specimen collection device. |
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| 862.1678 | Tacrolimus test system. |
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| 862.1680 | Testosterone test system. |
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| 862.1685 | Thyroxine-binding globulin test system. |
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| 862.1690 | Thyroid stimulating hormone test system. |
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| 862.1695 | Free thyroxine test system. |
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| 862.1700 | Total thyroxine test system. |
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| 862.1705 | Triglyceride test system. |
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| 862.1710 | Total triiodothyronine test system. |
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| 862.1715 | Triiodothyronine uptake test system. |
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| 862.1720 | Triose phosphate isomerase test system. |
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| 862.1725 | Trypsin test system. |
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| 862.1730 | Free tyrosine test system. |
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| 862.1770 | Urea nitrogen test system. |
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| 862.1775 | Uric acid test system. |
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| 862.1780 | Urinary calculi (stones) test system. |
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| 862.1785 | Urinary urobilinogen (nonquantitative) test system. |
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| 862.1790 | Uroporphyrin test system. |
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| 862.1795 | Vanilmandelic acid test system. |
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| 862.1805 | Vitamin A test system. |
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| 862.1810 | Vitamin B&bdi1;&bdi2; test system. |
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| 862.1815 | Vitamin E test system. |
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| 862.1820 | Xylose test system. |
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| 862.1825 | Vitamin D test system. |
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| 862.2050 | General purpose laboratory equipment labeled or promoted for a specific medical use. |
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| 862.2100 | Calculator/data processing module for clinical use. |
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| 862.2140 | Centrifugal chemistry analyzer for clinical use. |
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| 862.2150 | Continuous flow sequential multiple chemistry analyzer for clinical use. |
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| 862.2160 | Discrete photometric chemistry analyzer for clinical use. |
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| 862.2170 | Micro chemistry analyzer for clinical use. |
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| 862.2230 | Chromatographic separation material for clinical use. |
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| 862.2250 | Gas liquid chromatography system for clinical use. |
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| 862.2260 | High pressure liquid chromatography system for clinical use. |
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| 862.2270 | Thin-layer chromatography system for clinical use. |
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| 862.2300 | Colorimeter, photometer, or spectrophotometer for clinical use. |
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| 862.2310 | Clinical sample concentrator. |
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| 862.2320 | Beta or gamma counter for clinical use. |
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| 862.2400 | Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use. |
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| 862.2485 | Electrophoresis apparatus for clinical use. |
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| 862.2500 | Enzyme analyzer for clinical use. |
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| 862.2540 | Flame emission photometer for clinical use. |
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| 862.2560 | Fluorometer for clinical use. |
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| 862.2570 | Instrumentation for clinical multiplex test systems. |
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| 862.2680 | Microtitrator for clinical use. |
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| 862.2700 | Nephelometer for clinical use. |
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| 862.2720 | Plasma oncometer for clinical use. |
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| 862.2730 | Osmometer for clinical use. |
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| 862.2750 | Pipetting and diluting system for clinical use. |
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| 862.2800 | Refractometer for clinical use. |
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| 862.2850 | Atomic absorption spectrophotometer for clinical use. |
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| 862.2860 | Mass spectrometer for clinical use. |
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| 862.2900 | Automated urinalysis system. |
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| 862.2920 | Plasma viscometer for clinical use. |
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| 862.3030 | Acetaminophen test system. |
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| 862.3035 | Amikacin test system. |
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| 862.3040 | Alcohol test system. |
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| 862.3050 | Breath-alcohol test system. |
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| 862.3080 | Breath nitric oxide test system. |
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| 862.3100 | Amphetamine test system. |
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| 862.3110 | Antimony test system. |
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| 862.3120 | Arsenic test system. |
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| 862.3150 | Barbiturate test system. |
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| 862.3170 | Benzodiazepine test system. |
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| 862.3200 | Clinical toxicology calibrator. |
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| 862.3220 | Carbon monoxide test system. |
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| 862.3240 | Cholinesterase test system. |
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| 862.3250 | Cocaine and cocaine metabolite test system. |
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| 862.3270 | Codeine test system. |
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| 862.3280 | Clinical toxicology control material. |
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| 862.3300 | Digitoxin test system. |
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| 862.3320 | Digoxin test system. |
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| 862.3350 | Diphenylhydantoin test system. |
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| 862.3360 | Drug metabolizing enzyme genotyping system. |
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| 862.3380 | Ethosuximide test system. |
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| 862.3450 | Gentamicin test system. |
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| 862.3520 | Kanamycin test system. |
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| 862.3550 | Lead test system. |
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| 862.3555 | Lidocaine test system. |
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| 862.3560 | Lithium test system. |
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| 862.3580 | Lysergic acid diethylamide (LSD) test system. |
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| 862.3600 | Mercury test system. |
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| 862.3610 | Methamphetamine test system. |
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| 862.3620 | Methadone test system. |
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| 862.3630 | Methaqualone test system. |
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| 862.3640 | Morphine test system. |
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| 862.3645 | Neuroleptic drugs radioreceptor assay test system. |
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| 862.3650 | Opiate test system. |
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| 862.3660 | Phenobarbital test system. |
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| 862.3670 | Phenothiazine test system. |
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| 862.3680 | Primidone test system. |
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| 862.3700 | Propoxyphene test system. |
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| 862.3750 | Quinine test system. |
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| 862.3830 | Salicylate test system. |
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| 862.3840 | Sirolimus test system. |
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| 862.3850 | Sulfonamide test system. |
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| 862.3870 | Cannabinoid test system. |
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| 862.3880 | Theophylline test system. |
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| 862.3900 | Tobramycin test system. |
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| 862.3910 | Tricyclic antidepressant drugs test system. |
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| 862.3950 | Vancomycin test system. |
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