Data / Medical devices / Antigens, Nontreponemal, All / United States
FDA-registered makers of Antigens, Nontreponemal, All in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Antigens, Nontreponemal, All (product code GMQ). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Antigens, Nontreponemal, All
- Product code
- GMQ
- Country
- United States
Makers of Antigens, Nontreponemal, All in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Arlington Scientific, Inc. | Springville, UT, United States | Manufacturer | 2 | October 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| Gold Standard Diagnostics, LLC | Davis, CA, United States | Manufacturer, Repackager or relabeler | 2 | October 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer, Repackager or relabeler | 2 | March 10, 1987 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer, Repackager or relabeler | 2 | March 30, 1988 | 0 | 0 | 0 | api.fda.gov |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 1 | March 10, 1987 | 0 | 0 | 0 | api.fda.gov |
| KSL Biomedical, Inc. | Buffalo, NY, United States | Manufacturer | 1 | March 10, 1987 | 0 | 0 | 0 | api.fda.gov |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | May 23, 1988 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chembio Diagnostic Systems, Inc. | Medford, NY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chembio Diagnostic Systems | Bay Shore, NY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer for export | 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.