Product code POX

Device name

Enzyme Immunoassay, Oxcarbazepine Metabolite

Medical specialty

Clinical Toxicology

Device class

2

Regulation number

862.3645

Review panel

TX

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

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.

Source

FDA openFDA device classification dataset