# GNW: Antisera, Cf, Influenza Virus A, B, C

- Device class: 1; regulation: 21 CFR 866.3330; FDA's rule: 510(k) exempt
- FDA decisions: 16
- Recalls: 2 (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)
- 1991: 2
- 1994: 2
- 1996: 1
- 1997: 1
- 1998: 1
- 2000: 1
- 2002: 1
- 2006: 1
- 2008: 1
- 2009: 2

## Most-cited predicates
- K061101: D3 Ultra Dfa Respiratory Virus Screening & ID Kit (2006), cited by 7
- K022713: Dfa Respiratory Virus Screening & ID Kit (2002), cited by 1
- K896635: Viral Respiratory Indirect Fluores. Mono. Antibody (1990), cited by 1

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