| Device Type ID | 3129 |
| Device Name | Test, Donor, Cmv |
| Review Panel | Immunology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MZE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3129 |
| Device | Test, Donor, Cmv |
| Product Code | MZE |
| FDA Device Classification | Class 2 Medical Device |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
IMMUCOR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |