21 CFR § 862.3350 Clinical Chemistry and Clinical Toxicology Devices

§ 862.3350 Diphenylhydantoin test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(a) Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.

(b) Classification. Class II.

← § 862.3320 Digoxin test system.§ 862.3360 Drug metabolizing enzyme genotyping system. →