| Device Type ID | 3443 |
| Device Name | Candida Spp., Direct Antigen, Id |
| Regulation Description | Cryptococcus Neoformans 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 | 866.3165 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LRF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |