Clinical Chemistry Test Systems

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Clinical Chemistry and Clinical Toxicology Devices
  7. Clinical Chemistry Test Systems

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Section
862.1020

Acid phosphatase (total or prostatic) test system.

Section
862.1025

Adrenocorticotropic hormone (ACTH) test system.

Section
862.1030

Alanine amino transferase (ALT/SGPT) test system.

Section
862.1035

Albumin test system.

Section
862.1040

Aldolase test system.

Section
862.1045

Aldosterone test system.

Section
862.1050

Alkaline phosphatase or isoenzymes test system.

Section
862.1055

Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.

Section
862.1060

Delta-aminolevulinic acid test system.

Section
862.1065

Ammonia test system.

Section
862.1070

Amylase test system.

Section
862.1075

Androstenedione test system.

Section
862.1080

Androsterone test system.

Section
862.1085

Angiotensin I and renin test system.

Section
862.1090

Angiotensin converting enzyme (A.C.E.) test system.

Section
862.1095

Ascorbic acid test system.

Section
862.1100

Aspartate amino transferase (AST/SGOT) test system.

Section
862.1110

Bilirubin (total or direct) test system.

Section
862.1113

Bilirubin (total and unbound) in the neonate test system.

Section
862.1115

Urinary bilirubin and its conjugates (nonquantitative) test system.

Section
862.1117

B-type natriuretic peptide test system.

Section
862.1118

Biotinidase test system.

Section
862.1120

Blood gases (P<sub>CO2</sub>, P<sub>O2</sub>) and blood pH test system.

Section
862.1130

Blood volume test system.

Section
862.1135

C-peptides of proinsulin test system.

Section
862.1140

Calcitonin test system.

Section
862.1145

Calcium test system.

Section
862.1150

Calibrator.

Section
862.1155

Human chorionic gonadotropin (HCG) test system.

Section
862.1160

Bicarbonate/carbon dioxide test system.

Section
862.1163

Cardiac allograft gene expression profiling test system.

Section
862.1165

Catecholamines (total) test system.

Section
862.1170

Chloride test system.

Section
862.1175

Cholesterol (total) test system.

Section
862.1177

Cholylglycine test system.

Section
862.1180

Chymotrypsin test system.

Section
862.1185

Compound S (11-deoxycortisol) test system.

Section
862.1187

Conjugated sulfolithocholic acid (SLCG) test system.

Section
862.1190

Copper test system.

Section
862.1195

Corticoids test system.

Section
862.1200

Corticosterone test system.

Section
862.1205

Cortisol (hydrocortisone and hydroxycorticosterone) test system.

Section
862.1210

Creatine test system.

Section
862.1215

Creatine phosphokinase/creatine kinase or isoenzymes test system.

Section
862.1220

Acute kidney injury test system.

Section
862.1225

Creatinine test system.

Section
862.1230

Cyclic AMP test system.

Section
862.1235

Cyclosporine test system.

Section
862.1240

Cystine test system.

Section
862.1245

Dehydroepiandrosterone (free and sulfate) test system.

Section
862.1250

Desoxycorticosterone test system.

Section
862.1255

2,3-Diphosphoglyceric acid test system.

Section
862.1260

Estradiol test system.

Section
862.1265

Estriol test system.

Section
862.1270

Estrogens (total, in pregnancy) test system.

Section
862.1275

Estrogens (total, nonpregnancy) test system.

Section
862.1280

Estrone test system.

Section
862.1285

Etiocholanolone test system.

Section
862.1290

Fatty acids test system.

Section
862.1295

Folic acid test system.

Section
862.1300

Follicle-stimulating hormone test system.

Section
862.1305

Formiminoglutamic acid (FIGLU) test system.

Section
862.1310

Galactose test system.

Section
862.1315

Galactose-1-phosphate uridyl transferase test system.

Section
862.1320

Gastric acidity test system.

Section
862.1325

Gastrin test system.

Section
862.1330

Globulin test system.

Section
862.1335

Glucagon test system.

Section
862.1340

Urinary glucose (nonquantitative) test system.

Section
862.1345

Glucose test system.

Section
862.1350

Continuous glucose monitor secondary alarm system.

Section
862.1355

Integrated continuous glucose monitoring system.

Section
862.1356

Interoperable automated glycemic controller.

Section
862.1358

Insulin therapy adjustment device.

Section
862.1360

Gamma-glutamyl transpeptidase and isoenzymes test system.

Section
862.1365

Glutathione test system.

Section
862.1370

Human growth hormone test system.

Section
862.1373

Hemoglobin A1c test system.

Section
862.1375

Histidine test system.

Section
862.1377

Urinary homocystine (nonquantitative) test system.

Section
862.1380

Hydroxybutyric dehydrogenase test system.

Section
862.1385

17-Hydroxycorticosteroids (17-ketogenic steroids) test system.

Section
862.1390

5-Hydroxyindole acetic acid/serotonin test system.

Section
862.1395

17-Hydroxyprogesterone test system.

Section
862.1400

Hydroxyproline test system.

Section
862.1405

Immunoreactive insulin test system.

Section
862.1410

Iron (non-heme) test system.

Section
862.1415

Iron-binding capacity test system.

Section
862.1420

Isocitric dehydrogenase test system.

Section
862.1430

17-Ketosteroids test system.

Section
862.1435

Ketones (nonquantitative) test system.

Section
862.1440

Lactate dehydrogenase test system.

Section
862.1445

Lactate dehydrogenase isoenzymes test system.

Section
862.1450

Lactic acid test system.

Section
862.1455

Lecithin/sphingomyelin ratio in amniotic fluid test system.

Section
862.1460

Leucine aminopeptidase test system.

Section
862.1465

Lipase test system.

Section
862.1470

Lipid (total) test system.

Section
862.1475

Lipoprotein test system.

Section
862.1485

Luteinizing hormone test system.

Section
862.1490

Lysozyme (muramidase) test system.

Section
862.1495

Magnesium test system.

Section
862.1500

Malic dehydrogenase test system.

Section
862.1505

Mucopolysaccharides (nonquantitative) test system.

Section
862.1509

Methylmalonic acid (nonquantitative) test system.

Section
862.1510

Nitrite (nonquantitative) test system.

Section
862.1515

Nitrogen (amino-nitrogen) test system.

Section
862.1520

5&#x2032;-Nucleotidase test system.

Section
862.1530

Plasma oncometry test system.

Section
862.1535

Ornithine carbamyl transferase test system.

Section
862.1540

Osmolality test system.

Section
862.1542

Oxalate test system.

Section
862.1545

Parathyroid hormone test system.

Section
862.1550

Urinary pH (nonquantitative) test system.

Section
862.1555

Phenylalanine test system.

Section
862.1560

Urinary phenylketones (nonquantitative) test system.

Section
862.1565

6-Phosphogluconate dehydrogenase test system.

Section
862.1570

Phosphohexose isomerase test system.

Section
862.1575

Phospholipid test system.

Section
862.1580

Phosphorus (inorganic) test system.

Section
862.1585

Human placental lactogen test system.

Section
862.1590

Porphobilinogen test system.

Section
862.1595

Porphyrins test system.

Section
862.1600

Potassium test system.

Section
862.1605

Pregnanediol test system.

Section
862.1610

Pregnanetriol test system.

Section
862.1615

Pregnenolone test system.

Section
862.1620

Progesterone test system.

Section
862.1625

Prolactin (lactogen) test system.

Section
862.1630

Protein (fractionation) test system.

Section
862.1635

Total protein test system.

Section
862.1640

Protein-bound iodine test system.

Section
862.1645

Urinary protein or albumin (nonquantitative) test system.

Section
862.1650

Pyruvate kinase test system.

Section
862.1655

Pyruvic acid test system.

Section
862.1660

Quality control material (assayed and unassayed).

Section
862.1665

Sodium test system.

Section
862.1670

Sorbitol dehydrogenase test system.

Section
862.1675

Blood specimen collection device.

Section
862.1678

Tacrolimus test system.

Section
862.1680

Testosterone test system.

Section
862.1685

Thyroxine-binding globulin test system.

Section
862.1690

Thyroid stimulating hormone test system.

Section
862.1695

Free thyroxine test system.

Section
862.1700

Total thyroxine test system.

Section
862.1705

Triglyceride test system.

Section
862.1710

Total triiodothyronine test system.

Section
862.1715

Triiodothyronine uptake test system.

Section
862.1720

Triose phosphate isomerase test system.

Section
862.1725

Trypsin test system.

Section
862.1730

Free tyrosine test system.

Section
862.1770

Urea nitrogen test system.

Section
862.1775

Uric acid test system.

Section
862.1780

Urinary calculi (stones) test system.

Section
862.1785

Urinary urobilinogen (nonquantitative) test system.

Section
862.1790

Uroporphyrin test system.

Section
862.1795

Vanilmandelic acid test system.

Section
862.1805

Vitamin A test system.

Section
862.1810

Vitamin B<sub>12</sub> test system.

Section
862.1815

Vitamin E test system.

Section
862.1820

Xylose test system.

Section
862.1825

Vitamin D test system.

Section
862.1840

Total 25-hydroxyvitamin D mass spectrometry test system.