# GNX: Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

- Device class: 1; regulation: 21 CFR 866.3330; FDA's rule: 510(k) exempt
- FDA decisions: 18
- Recalls: 6 (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)
- 1981: 1
- 1985: 2
- 1987: 2
- 1988: 2
- 1990: 2
- 1992: 1
- 1997: 1
- 2012: 1
- 2013: 6

## Most-cited predicates
- K131606: Sofia Influenza a+B Fia (2013), cited by 2

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