| Device Type ID | 2477 |
| Device Name | Monitor,test,hiv-1 |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | Contact ODE |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MTL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2477 |
| Device | Monitor,test,hiv-1 |
| Product Code | MTL |
| FDA Device Classification | Class 3 Medical Device |