| Device Type ID | 3404 |
| Device Name | Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae |
| Regulation Description | Neisseria Spp. Direct Serological Test Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(k) |
| CFR Regulation Number | 866.3390 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LIC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |