21 CFR 862.3350 — Enzyme Immunoassay, Diphenylhydantoin

Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3350

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
DIPEnzyme Immunoassay, Diphenylhydantoin2443rd Party
DKHGas Chromatography, Diphenylhydantoin223rd Party
DLPRadioimmunoassay, Diphenylhydantoin253rd Party
DOZLiquid Chromatography, Diphenylhydantoin213rd Party
DPEThin Layer Chromatography, Diphenylhydantoin213rd Party
LDCU.V. Spectrometry, Diphenylhydantoin203rd Party
LESFluorescent Immunoassay, Diphenylhydantoin273rd Party
LFONephelometric Inhibition Immunoassay, Diphenylhydantoin213rd Party
LGRFluorescence Polarization Immunoassay, Diphenylhydantoin (Total)2153rd Party
MOJFluorescence Polarization Immunoassay, Diphenylhydantoin (Free)233rd Party
MSLSystem, Test, Topiramatee21
NWMImmunoassay, Anti-Seizure Drug253rd Party
ORHLamotrigine Assay223rd Party
ORILevetiracetam Assay223rd Party
OTFGabapentin Assay213rd Party
Innolitics

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