Data / Medical devices / System, Fibrinogen Determination
System, Fibrinogen Determination (KQJ): 9 FDA-registered makers in 4 countries
9 establishments in 4 countries are registered with the FDA to make System, Fibrinogen Determination (product code KQJ, Class 2, 21 CFR 864.7340). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 28 510(k) clearances under this code, the latest on July 24, 2025, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KQJ
- Device class
- 2
- Regulation
- 864.7340
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| France | 2 |
| Germany | 1 |
| Ireland | 1 |
Makers of System, Fibrinogen Determination
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 |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer | 4 | June 29, 2005 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer | 3 | July 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Tcoag Ireland Limited | BRAY Wicklow, Ireland | Manufacturer | 2 | October 9, 1997 | 0 | 0 | 0 | api.fda.gov |
| Diagnostica Stago - Taverny | Taverny Val-d'Oise, France | Exporter to the US, Manufacturer | 1 | March 2, 1984 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer | 1 | May 30, 1980 | 0 | 1 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 1 | May 2, 1984 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Bedford, MA, United States | Specification developer | 1 | July 24, 2025 | 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 | |
| R2 Diagnostics, Inc. | South Bend, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 24, 2025. 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.