# GQL: Antisera, Fluorescent, Herpesvirus Hominis 1,2

- Device class: 2; regulation: 21 CFR 866.3305; FDA's rule: 510(k) required
- FDA decisions: 37
- 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)
- 1982: 3
- 1983: 5
- 1984: 2
- 1985: 8
- 1987: 1
- 1989: 3
- 1990: 3
- 1991: 2
- 1999: 2
- 2009: 2

## Most-cited predicates
- K904167: Pathodx Herpes Typing (1990), cited by 2
- K902662: Bartels Herpes Simplex Vir Flu Mono Antibody Test (1990), cited by 1

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