Data / Medical devices / Test, Time, Prothrombin / United States
FDA-registered makers of Test, Time, Prothrombin in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Test, Time, Prothrombin (product code GJS). 9 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Test, Time, Prothrombin
- Product code
- GJS
- Country
- United States
Makers of Test, Time, Prothrombin in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer, Manufacturer for export | 5 | August 16, 2022 | 0 | 0 | 0 | api.fda.gov |
| Coagusense Inc | Fremont, CA, United States | Manufacturer, Repackager or relabeler | 3 | October 5, 2022 | 0 | 0 | 0 | api.fda.gov |
| Diagnostica Stago, Inc. | Parsippany, NJ, United States | Complaint file establishment, Manufacturer for export | 3 | December 23, 2022 | 0 | 4 | 0 | api.fda.gov |
| Accriva Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 2 | September 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Specification developer | 2 | February 20, 2001 | 0 | 0 | 0 | api.fda.gov |
| Abbott Point Of Care Inc. | Princeton, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | July 14, 2023 | 0 | 5 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer | 1 | February 14, 1995 | 0 | 2 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer for export, Repackager or relabeler | 1 | May 24, 2004 | 0 | 0 | 0 | api.fda.gov |
| R2 Diagnostics, Inc. | South Bend, IN, United States | Manufacturer | 1 | May 24, 2004 | 0 | 0 | 0 | api.fda.gov |
| Cliniqa Corporation | San Marcos, CA, United States | Contract 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 | |
| Nova Biomedical Corporation | Waltham, MA, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.