Research Use Only/immunology Devices
Device Code: 3137
Product Code(s):
OTR Definition: For Research Use Only And For Products Imported Into The US Only.
Device Classification Information
| Device Type ID | 3137 |
| Device Name | Research Use Only/immunology Devices |
| Physical State | N/A |
| Technical Method | N/A |
| Target Area | N/A |
| Review Panel | Immunology |
| 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 | OTR |
| GMP Exempt | Yes |
| 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 | 3137 |
| Device | Research Use Only/immunology Devices |
| Product Code | OTR |
| Recalls |
|---|
| Manufacturer | Recall Class | Date Posted |
| 1 | Diagnostic Hybrids, Inc. | III | Apr-24-2018 |
TPLC Last Update: 2019-04-02 20:24:26