Research Use Only/clinical Chemistry Devices
Device Code: 711
Product Code(s):
OTV Definition: For Research Use Only And For Products Imported Into The US Only.
Device Classification Information
| Device Type ID | 711 |
| Device Name | Research Use Only/clinical Chemistry Devices |
| Physical State | N/A |
| Technical Method | N/A |
| Target Area | N/A |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | Enforcement Discretion |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | OTV |
| GMP Exempt | Yes |
| 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 | 711 |
| Device | Research Use Only/clinical Chemistry Devices |
| Product Code | OTV |
| Device Problems |
|---|
Contamination / Decontamination Problem | 1 |
| Total Device Problems | 1 |
TPLC Last Update: 2019-04-02 19:39:17