Enzyme Immunoassay, Oxcarbazepine Metabolite

POX · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3645

Classification

FDA Product Code: POX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.3645
Review panel: TX
Medical specialty: Clinical Toxicology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

An Oxcarbazepine Metabolite Assay is an enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown