Voriconazole Test System
Device Code: 6259
Product Code(s):
PUJ Definition: A Voriconazole Test System Is A Device Intended To Measure Voriconazole In Human Serum. Measurements Obtained By This Device Are Used In Monitoring Levels Of Voriconazole To Ensure Appropriate Therapy.
Device Classification Information
| Device Type ID | 6259 |
| Device Name | Voriconazole Test System |
| Physical State | In Vitro Diagnostic Device |
| Technical Method | Immunoassay |
| Target Area | Serum |
| 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 | 862.3970 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PUJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 6259 |
| Device | Voriconazole Test System |
| Product Code | PUJ |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 862.3970 [🔎] |
TPLC Last Update: 2019-04-02 21:19:30