| Device Type ID | 3394 |
| Device Name | Gonococcal Antibody Tests |
| Regulation Description | Gonococcal Antibody Test (GAT). |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| CFR Regulation Number | 866.3290 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LGB |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3394 |
| Device | Gonococcal Antibody Tests |
| Product Code | LGB |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Gonococcal Antibody Test (GAT). |
| CFR Regulation Number | 866.3290 [🔎] |