Data / Medical devices / Reagent, Russel Viper Venom
Reagent, Russel Viper Venom (GIR): 9 FDA-registered makers in 4 countries
9 establishments in 4 countries are registered with the FDA to make Reagent, Russel Viper Venom (product code GIR, Class 1, 21 CFR 864.8950). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on January 10, 2014, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GIR
- Device class
- 1
- Regulation
- 864.8950
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Canada | 2 |
| Germany | 2 |
| France | 1 |
Makers of Reagent, Russel Viper Venom
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| DSRV, Inc. | Mount Olive, NJ, United States | Manufacturer | 4 | January 10, 2014 | 0 | 0 | 0 | api.fda.gov |
| Precision BioLogic Inc. | Dartmouth Nova Scotia, Canada | Manufacturer | 2 | July 28, 1999 | 0 | 0 | 0 | api.fda.gov |
| Biomedica Diagnostics Inc. | Windsor Nova Scotia, Canada | Manufacturer | 1 | April 5, 1995 | 0 | 0 | 0 | api.fda.gov |
| Diagnostica Stago - Taverny | Taverny Val-d'Oise, France | Exporter to the US, Manufacturer | 1 | December 6, 2006 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer | 1 | August 24, 2011 | 0 | 0 | 0 | api.fda.gov |
| R2 Diagnostics, Inc. | South Bend, IN, United States | Manufacturer | 1 | June 25, 2010 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer, Specification developer | 1 | April 6, 1993 | 0 | 0 | 0 | api.fda.gov |
| BIT Analytical Solutions GmbH | SCHWALBACH/TAUNUS Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 10, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.