FDA product code PRA: Variola Virus Nucleic Acid-Based Detection Assay
PRA is the FDA product code for variola virus nucleic acid-based detection assay. It is a Class II device, regulated under 21 CFR 866.3316 and reviewed by the Microbiology panel. Devices under PRA reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
The Variola virus nucleic acid-based detection assay is intended for individuals presenting with pustular or vesicular rash illness or other signs and symptoms of Variola virus infection. The test results must be used in conjunction with other diagnostic assays and clinical observations, as an aid to the diagnosis of infection, in accordance with the criteria defined by the appropriate public health authorities with the Federal government.
Classification
| Field | Value |
|---|---|
| Device name | Variola Virus Nucleic Acid-Based Detection Assay |
| Device class | Class II |
| Regulation | 21 CFR 866.3316 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for PRA devices
openFDA lists no recalls for product code PRA.
Frequently asked questions
What is FDA product code PRA?
PRA is the FDA product code for variola virus nucleic acid-based detection assay. It is a Class II device, regulated under 21 CFR 866.3316 and reviewed by the Microbiology panel.
What device class is PRA?
Class II, regulation 21 CFR 866.3316. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PRA
- Run a recall and safety report across every PRA manufacturer
- Watch product code PRA 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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