21 CFR § 862.3380 Clinical Chemistry and Clinical Toxicology Devices

§ 862.3380 Ethosuximide test system.

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

⚠ 2 pending changes to Part 862

(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.

← § 862.3364 Pharmacogenetic assessment system.§ 862.3450 Gentamicin test system. →