21 C.F.R. § 862.3350
Diphenylhydantoin test system.
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.