Data / Medical devices / Test, Qualitative And Quantitative Factor Deficiency / United States
FDA-registered makers of Test, Qualitative And Quantitative Factor Deficiency in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Test, Qualitative And Quantitative Factor Deficiency (product code GGP). 8 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.
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- Device
- Test, Qualitative And Quantitative Factor Deficiency
- Product code
- GGP
- Country
- United States
Makers of Test, Qualitative And Quantitative Factor Deficiency in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer, Repackager or relabeler | 16 | December 22, 1998 | 0 | 1 | 0 | api.fda.gov |
| INSTRUMENTATION LABORATORY CO. - Devens | Devens, MA, United States | Manufacturer for export, Repackager or relabeler | 13 | December 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer, Manufacturer for export, Repackager or relabeler | 10 | December 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Corgenix, Inc. | Broomfield, CO, United States | Manufacturer, Manufacturer for export | 5 | April 5, 2004 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Bedford, MA, United States | Specification developer | 5 | December 13, 2023 | 0 | 2 | 0 | api.fda.gov |
| Chrono-Log Corp. | Havertown, PA, United States | Repackager or relabeler, Specification developer | 1 | January 11, 1995 | 0 | 0 | 0 | api.fda.gov |
| Immucor GTI Diagnostics, Inc. | Waukesha, WI, United States | Manufacturer | 1 | November 20, 2008 | 0 | 0 | 0 | api.fda.gov |
| R2 Diagnostics, Inc. | South Bend, IN, United States | Manufacturer | 1 | December 17, 2008 | 0 | 0 | 0 | api.fda.gov |
| DSRV, Inc. | Mount Olive, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov |
Updated November 3, 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.