Data / Medical devices / Antigens, Nontreponemal, All
Antigens, Nontreponemal, All (GMQ): 14 FDA-registered makers in 2 countries
14 establishments in 2 countries are registered with the FDA to make Antigens, Nontreponemal, All (product code GMQ, Class 2, 21 CFR 866.3820). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 32 510(k) clearances under this code, the latest on October 10, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GMQ
- Device class
- 2
- Regulation
- 866.3820
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 12 |
| United Kingdom | 2 |
Makers of Antigens, Nontreponemal, All
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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| Axis-Shield Diagnostics, Ltd. | DUNDEE Scotland, United Kingdom | Contract manufacturer | 0 | 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 | |
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 10, 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.