Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
The Coccidioides spp. Nucleic Acid Detection System for Respiratory Specimens is a qualitative in vitro diagnostic test for the detection of Coccidioides spp. nucleic acids directly in clinical respiratory specimens from patients with signs and symptoms of coccidioidomycosis (Valley fever) and suspicion of infection. It is classified as a Class 2 device under regulation 866.3376, requiring 510(k) premarket notification, and falls within the Microbiology (MI) medical specialty. The product code is QAA. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QAA
- Device Class
- FDA class 2
- Regulation Number
- 866.3376
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN170041 | GeneSTAT.MDx Coccidioides Assay | Nov 29, 2017 | Unknown | Dxna, LLC |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.