# GQX: Antiserum, Cf, Varicella-Zoster

- Device class: 2; regulation: 21 CFR 866.3900; FDA's rule: 510(k) required
- FDA decisions: 11
- Recalls: 1 (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)
- 1977: 2
- 1984: 1
- 1985: 2
- 1986: 1
- 1987: 1
- 1988: 1
- 1989: 1
- 1991: 1
- 1996: 1

## Most-cited predicates
- K951799: Varicella-Zoster Virus Direct Immunofluorescence Assay (1996), cited by 2

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