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Title 21

Displaying title 21, up to date as of 7/16/2026. Title 21 was last amended 7/09/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter HMedical Devices800 – 898
Part 862Clinical Chemistry and Clinical Toxicology Devices862.1 – 862.3970
Subpart DClinical Toxicology Test Systems862.3030 – 862.3970
§ 862.3030Acetaminophen test system.
§ 862.3035Amikacin test system.
§ 862.3040Alcohol test system.
§ 862.3050Breath-alcohol test system.
§ 862.3080Breath nitric oxide test system.
§ 862.3100Amphetamine test system.
§ 862.3110Antimony test system.
§ 862.3120Arsenic test system.
§ 862.3150Barbiturate test system.
§ 862.3170Benzodiazepine test system.
§ 862.3200Clinical toxicology calibrator.
§ 862.3220Carbon monoxide test system.
§ 862.3240Cholinesterase test system.
§ 862.3245Clozapine test system.
§ 862.3250Cocaine and cocaine metabolite test system.
§ 862.3270Codeine test system.
§ 862.3280Clinical toxicology control material.
§ 862.3300Digitoxin test system.
§ 862.3320Digoxin test system.
§ 862.3350Diphenylhydantoin test system.
§ 862.3360Drug metabolizing enzyme genotyping system.
§ 862.3364Pharmacogenetic assessment system.
§ 862.3380Ethosuximide test system.
§ 862.3450Gentamicin test system.
§ 862.3460Plazomicin test system.
§ 862.3520Kanamycin test system.
§ 862.3550Lead test system.
§ 862.3555Lidocaine test system.
§ 862.3560Lithium test system.
§ 862.3580Lysergic acid diethylamide (LSD) test system.
§ 862.3590Meprobamate test system.
§ 862.3600Mercury test system.
§ 862.3610Methamphetamine test system.
§ 862.3620Methadone test system.
§ 862.3630Methaqualone test system.
§ 862.3640Morphine test system.
§ 862.3645Neuroleptic drugs radioreceptor assay test system.
§ 862.3650Opiate test system.
§ 862.3652Organophosphate test system.
§ 862.3660Phenobarbital test system.
§ 862.3670Phenothiazine test system.
§ 862.3680Primidone test system.
§ 862.3700Propoxyphene test system.
§ 862.3750Quinine test system.
§ 862.3800Reagents for molecular diagnostic instrument test systems.
§ 862.3830Salicylate test system.
§ 862.3840Sirolimus test system.
§ 862.3850Sulfonamide test system.
§ 862.3870Cannabinoid test system.
§ 862.3880Theophylline test system.
§ 862.3900Tobramycin test system.
§ 862.3910Tricyclic antidepressant drugs test system.
§ 862.3950Vancomycin test system.
§ 862.3970Voriconazole test system.