21 C.F.R. PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart A--GENERAL PROVISIONS
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| Regulation of calibrators.
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| Effective dates of requirement for premarket approval.
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| Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B--CLINICAL CHEMISTRY TEST SYSTEMS
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| Acid phosphatase (total or prostatic) test system.
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| Adrenocorticotropic hormone (ACTH) test system.
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| Alanine amino transferase (ALT/SGPT) test system.
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| Alkaline phosphatase or isoenzymes test system.
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| Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.
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| Delta-aminolevulinic acid test system.
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| Androstenedione test system.
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| Androsterone test system.
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| Angiotensin I and renin test system.
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| Angiotensin converting enzyme (A.C.E.) test system.
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| Ascorbic acid test system.
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| Aspartate amino transferase (AST/SGOT) test system.
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| Bilirubin (total or direct) test system.
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| Bilirubin (total and unbound) in the neonate test system.
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| Urinary bilirubin and its conjugates (nonquantitative) test system.
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| B-type natriuretic peptide test system.
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| Blood gases (P2, P2) and blood pH test system.
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| Blood volume test system.
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| C-peptides of proinsulin test system.
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| Human chorionic gonadotropin (HCG) test system.
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| Bicarbonate/carbon dioxide test system.
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| Catecholamines (total) test system.
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| Cholesterol (total) test system.
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| Cholylglycine test system.
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| Chymotrypsin test system.
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| Compound S (11-deoxycortisol) test system.
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| Conjugated sulfolithocholic acid (SLCG) test system.
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| Corticosterone test system.
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| Cortisol (hydrocortisone and hydroxycorticosterone) test system.
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| Creatine phosphokinase/creatine kinase or isoenzymes test system.
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| Cyclosporine test system.
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| Dehydroepiandrosterone (free and sulfate) test system.
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| Desoxycorticosterone test system.
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| 2,3-Diphosphoglyceric acid test system.
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| Estrogens (total, in pregnancy) test system.
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| Estrogens (total, nonpregnancy) test system.
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| Etiocholanolone test system.
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| Follicle-stimulating hormone test system.
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| Formiminoglutamic acid (FIGLU) test system.
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| Galactose-1-phosphate uridyl transferase test system.
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| Gastric acidity test system.
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| Urinary glucose (nonquantitative) test system.
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| Gamma-glutamyl transpeptidase and isoenzymes test system.
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| Human growth hormone test system.
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| Urinary homocystine (nonquantitative) test system.
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| Hydroxybutyric dehydrogenase test system.
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| 17-Hydroxycorticosteroids (17-ketogenic steroids) test system.
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| 5-Hydroxyindole acetic acid/serotonin test system.
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| 17-Hydroxyprogesterone test system.
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| Hydroxyproline test system.
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| Immunoreactive insulin test system.
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| Iron (non-heme) test system.
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| Iron-binding capacity test system.
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| Isocitric dehydrogenase test system.
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| 17-Ketosteroids test system.
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| Ketones (nonquantitative) test system.
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| Lactate dehydrogenase test system.
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| Lactate dehydrogenase isoenzymes test system.
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| Lecithin/sphingomyelin ratio in amniotic fluid test system.
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| Leucine aminopeptidase test system.
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| Lipid (total) test system.
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| Luteinizing hormone test system.
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| Lysozyme (muramidase) test system.
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| Malic dehydrogenase test system.
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| Mucopolysaccharides (nonquantitative) test system.
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| Methylmalonic acid (nonquantitative) test system.
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| Nitrite (nonquantitative) test system.
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| Nitrogen (amino-nitrogen) test system.
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| 5′-Nucleotidase test system.
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| Plasma oncometry test system.
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| Ornithine carbamyl transferase test system.
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| Parathyroid hormone test system.
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| Urinary pH (nonquantitative) test system.
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| Phenylalanine test system.
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| Urinary phenylketones (nonquantitative) test system.
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| 6-Phosphogluconate dehydrogenase test system.
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| Phosphohexose isomerase test system.
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| Phospholipid test system.
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| Phosphorus (inorganic) test system.
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| Human placental lactogen test system.
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| Porphobilinogen test system.
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| Pregnanediol test system.
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| Pregnanetriol test system.
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| Pregnenolone test system.
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| Progesterone test system.
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| Prolactin (lactogen) test system.
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| Protein (fractionation) test system.
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| Total protein test system.
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| Protein-bound iodine test system.
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| Urinary protein or albumin (nonquantitative) test system.
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| Pyruvate kinase test system.
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| Pyruvic acid test system.
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| Quality control material (assayed and unassayed).
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| Sorbitol dehydrogenase test system.
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| Blood specimen collection device.
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| Testosterone test system.
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| Thyroxine-binding globulin test system.
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| Thyroid stimulating hormone test system.
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| Free thyroxine test system.
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| Total thyroxine test system.
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| Triglyceride test system.
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| Total triiodothyronine test system.
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| Triiodothyronine uptake test system.
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| Triose phosphate isomerase test system.
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| Free tyrosine test system.
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| Urea nitrogen test system.
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| Urinary calculi (stones) test system.
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| Urinary urobilinogen (nonquantitative) test system.
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| Uroporphyrin test system.
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| Vanilmandelic acid test system.
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Subpart C--CLINICAL LABORATORY INSTRUMENTS
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| General purpose laboratory equipment labeled or promoted for a specific medical use.
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| Calculator/data processing module for clinical use.
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| Centrifugal chemistry analyzer for clinical use.
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| Continuous flow sequential multiple chemistry analyzer for clinical use.
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| Discrete photometric chemistry analyzer for clinical use.
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| Micro chemistry analyzer for clinical use.
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| Chromatographic separation material for clinical use.
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| Gas liquid chromatography system for clinical use.
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| High pressure liquid chromatography system for clinical use.
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| Thin-layer chromatography system for clinical use.
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| Colorimeter, photometer, or spectrophotometer for clinical use.
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| Clinical sample concentrator.
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| Beta or gamma counter for clinical use.
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| Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.
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| Electrophoresis apparatus for clinical use.
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| Enzyme analyzer for clinical use.
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| Flame emission photometer for clinical use.
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| Fluorometer for clinical use.
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| Instrumentation for clinical multiplex test systems.
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| Microtitrator for clinical use.
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| Nephelometer for clinical use.
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| Plasma oncometer for clinical use.
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| Osmometer for clinical use.
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| Pipetting and diluting system for clinical use.
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| Refractometer for clinical use.
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| Atomic absorption spectrophotometer for clinical use.
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| Mass spectrometer for clinical use.
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| Automated urinalysis system.
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| Plasma viscometer for clinical use.
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Subpart D--CLINICAL TOXICOLOGY TEST SYSTEMS
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| Acetaminophen test system.
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| Breath-alcohol test system.
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| Breath nitric oxide test system.
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| Benzodiazepine test system.
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| Clinical toxicology calibrator.
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| Carbon monoxide test system.
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| Cholinesterase test system.
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| Cocaine and cocaine metabolite test system.
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| Clinical toxicology control material.
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| Diphenylhydantoin test system.
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| Drug metabolizing enzyme genotyping system.
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| Ethosuximide test system.
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| Lysergic acid diethylamide (LSD) test system.
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| Methamphetamine test system.
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| Methaqualone test system.
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| Neuroleptic drugs radioreceptor assay test system.
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| Phenobarbital test system.
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| Phenothiazine test system.
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| Propoxyphene test system.
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| Theophylline test system.
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| Tricyclic antidepressant drugs test system.
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