# GQN: Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2

- Device class: 2; regulation: 21 CFR 866.3305; FDA's rule: 510(k) required
- FDA decisions: 34
- 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)
- 1985: 5
- 1986: 2
- 1987: 2
- 1988: 10
- 1991: 1
- 1995: 1
- 1996: 1
- 1997: 3
- 1999: 1
- 2007: 2

## Most-cited predicates
- K971662: Elvis HSV ID/Typing Test System (1997), cited by 2

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