FDA product code PIQ: Reagents For Detection Of Norovirus Nucleic Acid
PIQ is the FDA product code for reagents for detection of norovirus nucleic acid. It is a Class II device, regulated under 21 CFR 866.3990 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under PIQ. The average 510(k) review took 89 days (median 89).
Definition
Qualitative in vitro diagnostic test for the rapid detection and differentiation of norovirus genogroup I and genogroup II from specimens e.g., stool collected from individuals with symptoms of acute gastroenteritis.
Classification
| Field | Value |
|---|---|
| Device name | Reagents For Detection Of Norovirus Nucleic Acid |
| Device class | Class II |
| Regulation | 21 CFR 866.3990 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PIQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 89 |
Compare with all 510(k) review times · Search every PIQ clearance
Top PIQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| R-Biopharm AG | 1 | 2017-08-21 |
Most recent PIQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K171511 | R-Biopharm AG | RIDA GENE Norovirus GI/GII | 2017-08-21 | 89 |
Recalls for PIQ devices
openFDA lists no recalls for product code PIQ.
Frequently asked questions
What is FDA product code PIQ?
PIQ is the FDA product code for reagents for detection of norovirus nucleic acid. It is a Class II device, regulated under 21 CFR 866.3990 and reviewed by the Microbiology panel.
What device class is PIQ?
Class II, regulation 21 CFR 866.3990. Typical premarket route: 510(k).
How long does a 510(k) take for product code PIQ?
Across 1 cleared submissions the average was 89 days from receipt to decision (median 89).
Which companies have the most PIQ clearances?
R-Biopharm AG (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PIQ
- Run a recall and safety report across every PIQ manufacturer
- Watch product code PIQ 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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