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U.S. Department of Health and Human Services

Product Classification

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Device enzyme immunoassay, oxcarbazepine metabolite
Regulation Description Neuroleptic drugs radioreceptor assay test system.
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.
Physical State In vitro reagents
Technical Method Enzyme immunoassay
Target Area For in vitro diagnostic use only
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodePOX
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3645
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons