Immunoassay, Anti-seizure Drug
Device Code: 6246
Product Code(s):
NWM Definition: To Aid In Management Of Patients Treated With Anti-seizure Drug.
Device Classification Information
| Device Type ID | 6246 |
| Device Name | Immunoassay, Anti-seizure Drug |
| Physical State | Liquid Reagents |
| Technical Method | Immunoassay Intented For Use On Clinical Chemistry Analyzers |
| Target Area | In Vitro Diagnostic |
| Regulation Description | Diphenylhydantoin 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 | 862.3350 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NWM |
| 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 | 6246 |
| Device | Immunoassay, Anti-seizure Drug |
| Product Code | NWM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diphenylhydantoin Test System. |
| CFR Regulation Number | 862.3350 [🔎] |
TPLC Last Update: 2019-04-02 21:19:19