| Device Type ID | 3442 |
| Device Name | Campylobacter Spp. |
| Regulation Description | Campylobacter Fetus Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3110 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LQP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3442 |
| Device | Campylobacter Spp. |
| Product Code | LQP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Campylobacter Fetus Serological Reagents. |
| CFR Regulation Number | 866.3110 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
TECHLAB, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |