510(k) DEN170041
DEN170041 is an FDA 510(k) premarket notification submitted by Dxna, LLC for the device "GeneSTAT.MDx Coccidioides Assay". The FDA issued a decision of De Novo Granted on November 29, 2017. The device falls under product code QAA (Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens), a Class II device regulated under 21 CFR 866.3376.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 29, 2017
- Date Received
- August 1, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
- Device Class
- Class II
- Regulation Number
- 866.3376
- Review Panel
- MI
- Submission Type
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.