FDA product code OUC: Norovirus Serological Reagent
OUC is the FDA product code for norovirus serological reagent. It is a Class II device, regulated under 21 CFR 866.3395 and reviewed by the Microbiology panel. Devices under OUC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
Norovirus serological reagents are devices that consist of antigens and antisera for the detection of anti-norovirus antibodies or norovirus antigens. The detection aids in the clinical laboratory diagnosis of norovirus infection in individuals with signs and/or symptoms of acute gastroenteritis, or in the determining the etiology of acute gastroenteritis outbreaks.
Classification
| Field | Value |
|---|---|
| Device name | Norovirus Serological Reagent |
| Device class | Class II |
| Regulation | 21 CFR 866.3395 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for OUC devices
openFDA lists no recalls for product code OUC.
Frequently asked questions
What is FDA product code OUC?
OUC is the FDA product code for norovirus serological reagent. It is a Class II device, regulated under 21 CFR 866.3395 and reviewed by the Microbiology panel.
What device class is OUC?
Class II, regulation 21 CFR 866.3395. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OUC
- Run a recall and safety report across every OUC manufacturer
- Watch product code OUC 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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