# GNB: Antisera, All Types, Shigella Spp.

- Device class: 2; regulation: 21 CFR 866.3660; FDA's rule: 510(k) exempt
- FDA decisions: 41
- Recalls: 3 (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)
- 1982: 1
- 1989: 1
- 1990: 1
- 1995: 14
- 1996: 24

## Most-cited predicates

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