21 C.F.R. § 862.3380

Ethosuximide test system.

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

Cite as 21 C.F.R. § 862.3380 (2026)

(a) Identification. An ethosuximide test system is a device intended to measure ethosuximide, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of ethosuximide overdose and in monitoring levels of ethosuximide to ensure appropriate therapy. (b) Classification. Class II.
21 C.F.R. § 862.3380: Ethosuximide test system. | Justis AI