POX

Enzyme Immunoassay, Oxcarbazepine Metabolite

Product code

POX

Device name

Enzyme Immunoassay, Oxcarbazepine Metabolite

Device class

Class 2

21 CFR

21 CFR 862.3645

Medical specialty

Clinical Toxicology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).