# LGC: Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

- Device class: 2; regulation: 21 CFR 866.3305; FDA's rule: 510(k) required
- FDA decisions: 38
- Recalls: 7 (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)
- 1990: 3
- 1991: 5
- 1992: 8
- 1996: 2
- 1997: 2
- 1998: 1
- 1999: 5
- 2000: 2
- 2001: 1
- 2003: 1

## Most-cited predicates
- K000238: HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G (2000), cited by 14
- K822883: Herpelisa Kit (1983), cited by 1

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