| Device Type ID | 3058 |
| Device Name | Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) |
| Regulation Description | Anti-Saccharomyces Cerevisiae (S. Cerevisiae) Antibody (ASCA) Test Systems. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(k) |
| CFR Regulation Number | 866.5785 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NBT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |