| Device Type ID | 3111 |
| Device Name | Test, Donor, Syphilis, Antigens, Treponemal |
| Regulation Description | Treponema Pallidum Treponemal Test Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Immunology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3830 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MYR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |