FDA product code QAA: Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
QAA is the FDA product code for coccidioides spp. nucleic acid detection system for respiratory specimens. It is a Class II device, regulated under 21 CFR 866.3376 and reviewed by the Microbiology panel. Devices under QAA reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens |
| Device class | Class II |
| Regulation | 21 CFR 866.3376 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for QAA devices
openFDA lists no recalls for product code QAA.
Frequently asked questions
What is FDA product code QAA?
QAA is the FDA product code for coccidioides spp. nucleic acid detection system for respiratory specimens. It is a Class II device, regulated under 21 CFR 866.3376 and reviewed by the Microbiology panel.
What device class is QAA?
Class II, regulation 21 CFR 866.3376. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QAA
- Run a recall and safety report across every QAA manufacturer
- Watch product code QAA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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