Data / Medical devices / Plasma, Coagulation Factor Deficient
Plasma, Coagulation Factor Deficient (GJT): 10 FDA-registered makers in 5 countries
10 establishments in 5 countries are registered with the FDA to make Plasma, Coagulation Factor Deficient (product code GJT, Class 2, 21 CFR 864.7290). 9 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 79 510(k) clearances under this code, the latest on September 13, 2023, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GJT
- Device class
- 2
- Regulation
- 864.7290
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Canada | 1 |
| France | 1 |
| Ireland | 1 |
| Germany | 1 |
Makers of Plasma, Coagulation Factor Deficient
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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| Precision BioLogic Inc. | Dartmouth Nova Scotia, Canada | Manufacturer | 10 | September 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Diagnostica Stago - Taverny | Taverny Val-d'Oise, France | Exporter to the US, Manufacturer | 9 | October 25, 1996 | 0 | 0 | 0 | api.fda.gov |
| Tcoag Ireland Limited | BRAY Wicklow, Ireland | Manufacturer | 8 | January 25, 1990 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer | 3 | June 8, 1993 | 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 September 13, 2023. 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.