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Electronic Code of Federal Regulations

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e-CFR Data is current as of August 20, 2014

Title 21Chapter ISubchapter HPart 862


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

rule

Subpart A—GENERAL PROVISIONS

§862.1
Scope.
§862.2
Regulation of calibrators.
§862.3
Effective dates of requirement for premarket approval.
§862.9
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
rule

Subpart B—CLINICAL CHEMISTRY TEST SYSTEMS

§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 (PCO2, PO2) and blood pH test system.
§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.
§862.1225
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.
§862.1360
Gamma-glutamyl transpeptidase and isoenzymes test system.
§862.1365
Glutathione test system.
§862.1370
Human growth hormone test system.
§862.1375
Histidine test system.
§862.1377
Urinary homocystine (nonquantitative) test system.
§862.1380
Hydroxybutyric dehydrogenase test system.
§862.1385
17-Hydroxycorticosteroids (17-ketogenic steroids) test system.
§862.1390
5-Hydroxyindole acetic acid/serotonin test system.
§862.1395
17-Hydroxyprogesterone test system.
§862.1400
Hydroxyproline test system.
§862.1405
Immunoreactive insulin test system.
§862.1410
Iron (non-heme) test system.
§862.1415
Iron-binding capacity test system.
§862.1420
Isocitric dehydrogenase test system.
§862.1430
17-Ketosteroids test system.
§862.1435
Ketones (nonquantitative) test system.
§862.1440
Lactate dehydrogenase test system.
§862.1445
Lactate dehydrogenase isoenzymes test system.
§862.1450
Lactic acid test system.
§862.1455
Lecithin/sphingomyelin ratio in amniotic fluid test system.
§862.1460
Leucine aminopeptidase test system.
§862.1465
Lipase test system.
§862.1470
Lipid (total) test system.
§862.1475
Lipoprotein test system.
§862.1485
Luteinizing hormone test system.
§862.1490
Lysozyme (muramidase) test system.
§862.1495
Magnesium test system.
§862.1500
Malic dehydrogenase test system.
§862.1505
Mucopolysaccharides (nonquantitative) test system.
§862.1509
Methylmalonic acid (nonquantitative) test system.
§862.1510
Nitrite (nonquantitative) test system.
§862.1515
Nitrogen (amino-nitrogen) test system.
§862.1520
5′-Nucleotidase test system.
§862.1530
Plasma oncometry test system.
§862.1535
Ornithine carbamyl transferase test system.
§862.1540
Osmolality test system.
§862.1542
Oxalate test system.
§862.1545
Parathyroid hormone test system.
§862.1550
Urinary pH (nonquantitative) test system.
§862.1555
Phenylalanine test system.
§862.1560
Urinary phenylketones (nonquantitative) test system.
§862.1565
6-Phosphogluconate dehydrogenase test system.
§862.1570
Phosphohexose isomerase test system.
§862.1575
Phospholipid test system.
§862.1580
Phosphorus (inorganic) test system.
§862.1585
Human placental lactogen test system.
§862.1590
Porphobilinogen test system.
§862.1595
Porphyrins test system.
§862.1600
Potassium test system.
§862.1605
Pregnanediol test system.
§862.1610
Pregnanetriol test system.
§862.1615
Pregnenolone test system.
§862.1620
Progesterone test system.
§862.1625
Prolactin (lactogen) test system.
§862.1630
Protein (fractionation) test system.
§862.1635
Total protein test system.
§862.1640
Protein-bound iodine test system.
§862.1645
Urinary protein or albumin (nonquantitative) test system.
§862.1650
Pyruvate kinase test system.
§862.1655
Pyruvic acid test system.
§862.1660
Quality control material (assayed and unassayed).
§862.1665
Sodium test system.
§862.1670
Sorbitol dehydrogenase test system.
§862.1675
Blood specimen collection device.
§862.1678
Tacrolimus test system.
§862.1680
Testosterone test system.
§862.1685
Thyroxine-binding globulin test system.
§862.1690
Thyroid stimulating hormone test system.
§862.1695
Free thyroxine test system.
§862.1700
Total thyroxine test system.
§862.1705
Triglyceride test system.
§862.1710
Total triiodothyronine test system.
§862.1715
Triiodothyronine uptake test system.
§862.1720
Triose phosphate isomerase test system.
§862.1725
Trypsin test system.
§862.1730
Free tyrosine test system.
§862.1770
Urea nitrogen test system.
§862.1775
Uric acid test system.
§862.1780
Urinary calculi (stones) test system.
§862.1785
Urinary urobilinogen (nonquantitative) test system.
§862.1790
Uroporphyrin test system.
§862.1795
Vanilmandelic acid test system.
§862.1805
Vitamin A test system.
§862.1810
Vitamin B12 test system.
§862.1815
Vitamin E test system.
§862.1820
Xylose test system.
§862.1825
Vitamin D test system.
rule

Subpart C—CLINICAL LABORATORY INSTRUMENTS

§862.2050
General purpose laboratory equipment labeled or promoted for a specific medical use.
§862.2100
Calculator/data processing module for clinical use.
§862.2140
Centrifugal chemistry analyzer for clinical use.
§862.2150
Continuous flow sequential multiple chemistry analyzer for clinical use.
§862.2160
Discrete photometric chemistry analyzer for clinical use.
§862.2170
Micro chemistry analyzer for clinical use.
§862.2230
Chromatographic separation material for clinical use.
§862.2250
Gas liquid chromatography system for clinical use.
§862.2260
High pressure liquid chromatography system for clinical use.
§862.2270
Thin-layer chromatography system for clinical use.
§862.2300
Colorimeter, photometer, or spectrophotometer for clinical use.
§862.2310
Clinical sample concentrator.
§862.2320
Beta or gamma counter for clinical use.
§862.2400
Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.
§862.2485
Electrophoresis apparatus for clinical use.
§862.2500
Enzyme analyzer for clinical use.
§862.2540
Flame emission photometer for clinical use.
§862.2560
Fluorometer for clinical use.
§862.2570
Instrumentation for clinical multiplex test systems.
§862.2680
Microtitrator for clinical use.
§862.2700
Nephelometer for clinical use.
§862.2720
Plasma oncometer for clinical use.
§862.2730
Osmometer for clinical use.
§862.2750
Pipetting and diluting system for clinical use.
§862.2800
Refractometer for clinical use.
§862.2850
Atomic absorption spectrophotometer for clinical use.
§862.2860
Mass spectrometer for clinical use.
§862.2900
Automated urinalysis system.
§862.2920
Plasma viscometer for clinical use.
rule

Subpart D—CLINICAL TOXICOLOGY TEST SYSTEMS

§862.3030
Acetaminophen test system.
§862.3035
Amikacin test system.
§862.3040
Alcohol test system.
§862.3050
Breath-alcohol test system.
§862.3080
Breath nitric oxide test system.
§862.3100
Amphetamine test system.
§862.3110
Antimony test system.
§862.3120
Arsenic test system.
§862.3150
Barbiturate test system.
§862.3170
Benzodiazepine test system.
§862.3200
Clinical toxicology calibrator.
§862.3220
Carbon monoxide test system.
§862.3240
Cholinesterase test system.
§862.3250
Cocaine and cocaine metabolite test system.
§862.3270
Codeine test system.
§862.3280
Clinical toxicology control material.
§862.3300
Digitoxin test system.
§862.3320
Digoxin test system.
§862.3350
Diphenylhydantoin test system.
§862.3360
Drug metabolizing enzyme genotyping system.
§862.3380
Ethosuximide test system.
§862.3450
Gentamicin test system.
§862.3520
Kanamycin test system.
§862.3550
Lead test system.
§862.3555
Lidocaine test system.
§862.3560
Lithium test system.
§862.3580
Lysergic acid diethylamide (LSD) test system.
§862.3600
Mercury test system.
§862.3610
Methamphetamine test system.
§862.3620
Methadone test system.
§862.3630
Methaqualone test system.
§862.3640
Morphine test system.
§862.3645
Neuroleptic drugs radioreceptor assay test system.
§862.3650
Opiate test system.
§862.3660
Phenobarbital test system.
§862.3670
Phenothiazine test system.
§862.3680
Primidone test system.
§862.3700
Propoxyphene test system.
§862.3750
Quinine test system.
§862.3830
Salicylate test system.
§862.3840
Sirolimus test system.
§862.3850
Sulfonamide test system.
§862.3870
Cannabinoid test system.
§862.3880
Theophylline test system.
§862.3900
Tobramycin test system.
§862.3910
Tricyclic antidepressant drugs test system.
§862.3950
Vancomycin test system.


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