Data / Medical devices / Test, Time, Partial Thromboplastin
Test, Time, Partial Thromboplastin (GGW): 13 FDA-registered makers in 5 countries
13 establishments in 5 countries are registered with the FDA to make Test, Time, Partial Thromboplastin (product code GGW, Class 2, 21 CFR 864.7925). 11 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 32 510(k) clearances under this code, the latest on March 20, 2026, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GGW
- Device class
- 2
- Regulation
- 864.7925
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| France | 3 |
| Canada | 2 |
| Germany | 1 |
| Switzerland | 1 |
Makers of Test, Time, 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 |
|---|---|---|---|---|---|---|---|---|
| Diagnostica Stago, Inc. | Parsippany, NJ, United States | Complaint file establishment, Manufacturer for export | 3 | June 9, 1992 | 0 | 1 | 0 | api.fda.gov |
| Diagnostica Stago - Taverny | Taverny Val-d'Oise, France | Exporter to the US, Manufacturer | 3 | June 9, 1992 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer | 3 | December 21, 1999 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer | 2 | December 23, 1996 | 0 | 0 | 0 | api.fda.gov |
| R2 Diagnostics, Inc. | South Bend, IN, United States | Manufacturer | 2 | December 30, 2010 | 0 | 0 | 0 | api.fda.gov |
| Biomedica Diagnostics Inc. | Windsor Nova Scotia, Canada | Manufacturer | 1 | December 22, 2004 | 0 | 0 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 1 | November 12, 1980 | 0 | 0 | 0 | api.fda.gov |
| Hemagen Diagnostics, Inc. | Baltimore, MD, United States | Manufacturer | 1 | July 14, 1980 | 0 | 0 | 0 | api.fda.gov |
| Hyphen Biomed Sasu | NEUVILLE SUR OISE Val-d'Oise, France | Manufacturer | 1 | May 8, 2009 | 0 | 0 | 0 | api.fda.gov |
| Pentapharm AG | Aesch Basel-Landschaft, Switzerland | Manufacturer | 1 | December 22, 2004 | 0 | 0 | 0 | api.fda.gov |
| Precision BioLogic Inc. | Dartmouth Nova Scotia, Canada | Manufacturer | 1 | January 13, 1999 | 0 | 0 | 0 | api.fda.gov |
| Diagnostica Stago - Gennevilliers | Gennevilliers Hauts-de-Seine, France | Exporter to the US, Manufacturer | 0 | 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 March 20, 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.