Data / Medical devices / Plasma, Coagulation Factor Deficient / United States
FDA-registered makers of Plasma, Coagulation Factor Deficient in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Plasma, Coagulation Factor Deficient (product code GJT). 5 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Plasma, Coagulation Factor Deficient
- Product code
- GJT
- Country
- United States
Makers of Plasma, Coagulation Factor Deficient in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Diagnostica Stago, Inc. | Parsippany, NJ, United States | Complaint file establishment, Manufacturer for export | 17 | October 25, 1996 | 0 | 1 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer | 10 | March 22, 2018 | 0 | 0 | 0 | api.fda.gov |
| R2 Diagnostics, Inc. | South Bend, IN, United States | Manufacturer | 2 | December 19, 2011 | 0 | 0 | 0 | api.fda.gov |
| Diapharma Group, Inc. | West Chester, OH, United States | Manufacturer | 1 | July 12, 2004 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer | 1 | February 17, 1999 | 0 | 0 | 0 | api.fda.gov |
| George King Bio-Medical, Inc. | Overland Park, KS, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.