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ARK™ Oxcarbazepine Metabolite Assay

ARK DIAGNOSTICS INC · Model 5032-0001-00 · UDI-DI 00858724003308

POX Prescription
1
510(k) clearances
0
Adverse events
0
Recalls
1
Facilities

Description

The ARK™ Oxcarbazepine Metabolite Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.