Docetaxel / Paclitaxel Assay
Device Code: 6298
Product Code(s):
PRF Definition: Measures Levels Of Docetaxel Or Paclitaxel In The Blood
Device Classification Information
| Device Type ID | 6298 |
| Device Name | Docetaxel / Paclitaxel Assay |
| Physical State | Measures Levels Of Docetaxel Or Paclitaxel In The Blood |
| Technical Method | Measures Levels Of Docetaxel Or Paclitaxel In The Blood |
| Target Area | 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 | PRF |
| 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 | 6298 |
| Device | Docetaxel / Paclitaxel Assay |
| Product Code | PRF |
TPLC Last Update: 2019-04-02 21:20:01