| Device Type ID | 2487 |
| Device Name | System, Test, Home, Hiv-1 |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MVZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2487 |
| Device | System, Test, Home, Hiv-1 |
| Product Code | MVZ |
| FDA Device Classification | Class 3 Medical Device |