# GQW: Antigen, Cf, (Including Cf Control), Varicella-Zoster

- Device class: 2; regulation: 21 CFR 866.3900; FDA's rule: 510(k) required
- FDA decisions: 10
- 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)
- 1980: 1
- 1985: 2
- 1989: 1
- 1990: 1
- 1991: 1
- 1994: 1
- 1997: 1
- 1999: 1
- 2007: 1

## Most-cited predicates
- K990141: Light Diagnostics Simulfluor HSV/VZV Immunoflourescence Assay, Model 3295 (1999), cited by 1

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