| Device Type ID | 3437 |
| Device Name | Dna-reagents, Legionella |
| Regulation Description | Haemophilus Spp. Serological Reagents. |
| 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 | 866.3300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LQH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3437 |
| Device | Dna-reagents, Legionella |
| Product Code | LQH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Haemophilus Spp. Serological Reagents. |
| CFR Regulation Number | 866.3300 [🔎] |