Data / Medical devices / Antithrombin Iii Quantitation
Antithrombin Iii Quantitation (JBQ): 11 FDA-registered makers in 6 countries
11 establishments in 6 countries are registered with the FDA to make Antithrombin Iii Quantitation (product code JBQ, Class 2, 21 CFR 864.7060). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 56 510(k) clearances under this code, the latest on March 28, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JBQ
- Device class
- 2
- Regulation
- 864.7060
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| France | 2 |
| United Kingdom | 2 |
| Germany | 1 |
| Ireland | 1 |
| Canada | 1 |
Makers of Antithrombin Iii Quantitation
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 - Taverny | Taverny Val-d'Oise, France | Exporter to the US, Manufacturer | 2 | January 24, 1991 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer | 2 | February 23, 2007 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer | 2 | March 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Tcoag Ireland Limited | BRAY Wicklow, Ireland | Manufacturer | 2 | July 25, 1997 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 1 | December 24, 1997 | 0 | 0 | 0 | api.fda.gov |
| Biomedica Diagnostics Inc. | Windsor Nova Scotia, Canada | Manufacturer | 1 | June 23, 1989 | 0 | 0 | 0 | api.fda.gov |
| Hyphen Biomed Sasu | NEUVILLE SUR OISE Val-d'Oise, France | Manufacturer | 1 | November 7, 2005 | 0 | 0 | 0 | api.fda.gov |
| Kent Laboratories, Inc. | Bellingham, WA, United States | Manufacturer | 1 | August 11, 1983 | 0 | 0 | 0 | api.fda.gov |
| The Binding Site | Kings Norton Birmingham, United Kingdom | Manufacturer | 1 | January 3, 1992 | 0 | 0 | 0 | api.fda.gov |
| The Binding Site Group Ltd. | Birmingham, United Kingdom | Complaint file establishment, Manufacturer | 1 | January 3, 1992 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 28, 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.