POX
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Enzyme Immunoassay, Oxcarbazepine Metabolite
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3645
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control (K153596) | Ark Diagnostics, Inc. | 2016-08-09 | + Add |
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Every clearance here is in the API, with alerts when new ones post.