21 CFR 862.3380 — Gas Chromatography, Ethosuximide

Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3380

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
DIYGas Chromatography, Ethosuximide213rd Party
DJXRadioimmunoassay, Ethosuximide203rd Party
DLFEnzyme Immunoassay, Ethosuximide293rd Party
DNFLiquid Chromatography, Ethosuximide203rd Party
DNPThin Layer Chromatography, Ethosuximide213rd Party
Innolitics

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