# OUC: Norovirus Serological Reagent

- Device class: 2; regulation: 21 CFR 866.3395; FDA's rule: 510(k) exempt
- FDA decisions: 1
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)

## Most-cited predicates
- DEN110001: Norovirus Serological Reagent (), cited by 1

Source page: https://510kreport.com/product-code/OUC
Data by year (CSV): https://510kreport.com/product-code/OUC.csv