QAA
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3376
- Medical specialty
- Microbiology
- FDA definition
- A Coccidioides spp. nucleic acid detection system for respiratory specimens is a qualitative test for the detection of Coccidioides spp. nucleic acids directly in clinical respiratory specimens from patients with signs and symptoms of coccidioidomycosis and suspicion of infection.
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| Record | Firm | Date |
|---|---|---|
| GeneSTAT.MDx Coccidioides Assay (DEN170041) | Dxna, LLC | 2017-11-29 |
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