QAA — Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens Class II
FDA product code QAA covers "Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens", a Class II medical device regulated under 21 CFR 866.3376. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QAA
- Device Class
- Class II
- Regulation Number
- 866.3376
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN170041 | dxna | GeneSTAT.MDx Coccidioides Assay | November 29, 2017 |