Enzyme Immunoassay, Oxcarbazepine Metabolite
Device Code: 6256
Product Code(s):
POX 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 Appr
Device Classification Information
| Device Type ID | 6256 |
| Device Name | Enzyme Immunoassay, Oxcarbazepine Metabolite |
| Physical State | In Vitro Reagents |
| Technical Method | Enzyme Immunoassay |
| Target Area | For In Vitro Diagnostic Use Only |
| Regulation Description | Neuroleptic Drugs Radioreceptor Assay Test System. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 862.3645 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | POX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 6256 |
| Device | Enzyme Immunoassay, Oxcarbazepine Metabolite |
| Product Code | POX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Neuroleptic Drugs Radioreceptor Assay Test System. |
| CFR Regulation Number | 862.3645 [🔎] |
TPLC Last Update: 2019-04-02 21:19:28