# Reagent, Russel Viper Venom
> **Product code: GIR** · Class I — Low Risk (general controls) · Hematology · 21 CFR 864.8950
## Classification
- **FDA Product Code:** GIR
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 864.8950
- **Review panel:** HE
- **Medical specialty:** Hematology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Market data
- **Cleared 510(k) submissions:** 16
- **Registered establishments:** 12
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=GIR)
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