Data / Medical devices / Activated Partial Thromboplastin
Activated Partial Thromboplastin (GFO): 10 FDA-registered makers in 5 countries
10 establishments in 5 countries are registered with the FDA to make Activated Partial Thromboplastin (product code GFO, Class 2, 21 CFR 864.7925). 9 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 52 510(k) clearances under this code, the latest on January 9, 2026, and lists 9 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GFO
- Device class
- 2
- Regulation
- 864.7925
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Canada | 2 |
| Germany | 1 |
| Ireland | 1 |
| France | 1 |
Makers of Activated Partial Thromboplastin
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 |
|---|---|---|---|---|---|---|---|---|
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer | 4 | March 16, 2016 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer | 2 | April 19, 1996 | 0 | 0 | 0 | api.fda.gov |
| Tcoag Ireland Limited | BRAY Wicklow, Ireland | Manufacturer | 2 | October 19, 1992 | 0 | 0 | 0 | api.fda.gov |
| Accriva Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 1 | November 20, 1997 | 0 | 1 | 0 | api.fda.gov |
| Biomedica Diagnostics Inc. | Windsor Nova Scotia, Canada | Manufacturer | 1 | November 1, 2002 | 0 | 0 | 0 | api.fda.gov |
| Diagnostica Stago - Taverny | Taverny Val-d'Oise, France | Exporter to the US, Manufacturer | 1 | December 23, 1992 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer | 1 | April 21, 1989 | 0 | 0 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer, Manufacturer for export | 1 | February 14, 1992 | 0 | 2 | 0 | api.fda.gov |
| Precision BioLogic Inc. | Dartmouth Nova Scotia, Canada | Manufacturer | 1 | October 23, 2020 | 0 | 0 | 0 | api.fda.gov |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 9, 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.