| Device Type ID | 3353 |
| Device Name | Kit, Identification, Neisseria Gonorrhoeae |
| Regulation Description | Microorganism Differentiation And Identification Device. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.2660 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JSX |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |