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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodePOX
Regulation Number 862.3645
Device Class 2

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