| Device Type ID | 2480 |
| Device Name | Antibody To Htlv-1, Elisa |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | Contact ODE |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MTP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2480 |
| Device | Antibody To Htlv-1, Elisa |
| Product Code | MTP |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
False Positive Result | 8 |
False Negative Result | 1 |
| Total Device Problems | 9 |