5-fluorouracil Assay
Device Code: 6294
Product Code(s):
OXR Definition: Measures Levels Of A Chemotherapy Drug In The Blood.
Device Classification Information
| Device Type ID | 6294 |
| Device Name | 5-fluorouracil Assay |
| Physical State | Measures Levels Of A Chemotherapy Drug In The Blood |
| Technical Method | Measures Levels Of A Chemotherapy Drug In The Blood |
| Target Area | The Blood |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | Contact ODE |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | OXR |
| 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 | 6294 |
| Device | 5-fluorouracil Assay |
| Product Code | OXR |
TPLC Last Update: 2019-04-02 21:19:58