FDA product code POX

Enzyme Immunoassay, Oxcarbazepine Metabolite

Clinical Toxicology·Class 2·21 CFR 862.3645
US regulatory classifications
US Product Code (FDA)
POX
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 862.3645
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Medical specialty
Clinical Toxicology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
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.

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About this record

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.