| Device Type ID | 3465 |
| Device Name | Pneumocystis Carinii |
| Regulation Description | Toxoplasma Gondii 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 | 866.3780 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LYF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3465 |
| Device | Pneumocystis Carinii |
| Product Code | LYF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Toxoplasma Gondii Serological Reagents. |
| CFR Regulation Number | 866.3780 [🔎] |