POX
2016-08-09
Enzyme Immunoassay, Oxcarbazepine Metabolite
FDA product code POX · 1 cleared devices
Class 2
Clinical Toxicology
- Regulation
- 21 CFR 862.3645
- Review panel
- TX
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 2016-08-09 – 2016-08-09
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.
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