21 C.F.R. § 862.3350

Diphenylhydantoin test system.

Last amended: 2016Year: 2026Length: 48 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 862.3350 (2026)

(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.
21 C.F.R. § 862.3350: Diphenylhydantoin test system. | Justis AI