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Enzyme Immunoassay, Oxcarbazepine Metabolite

Enzyme Immunoassay, Oxcarbazepine Metabolite is a medical device type in the Clinical Toxicology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

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Enzyme Immunoassay, Oxcarbazepine Metabolite
Clinical Toxicology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

POX

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Class 2

21 CFR 862.3645

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Clinical Toxicology

Device Characteristics

No

No

No

Eligible

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.