# GIR: Reagent, Russel Viper Venom

- Device class: 1; regulation: 21 CFR 864.8950; FDA's rule: 510(k) required
- FDA decisions: 16
- 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)
- 1984: 1
- 1990: 1
- 1993: 3
- 1995: 1
- 1999: 3
- 2000: 2
- 2006: 1
- 2010: 1
- 2011: 1
- 2014: 2

## Most-cited predicates
- K990302: IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm (Claims Addad to Acl Futura) (1999), cited by 3
- K922156: Lucor Confirmatory Reagent (1993), cited by 1
- K940490: DV Test and DVV Confirm (1995), cited by 1
- K061805: Sta - Staclot DRVV Screen; Sta - Staclot DRVV Confirm (2006), cited by 1
- K110031: Hemosil Drvvt Screen & Hemosil Drvvt Confirm (2011), cited by 1
- K922326: Lupo-Test Regeant (1993), cited by 1

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