Data / Medical devices / Antisera, Control For Nontreponemal Tests / United States
FDA-registered makers of Antisera, Control For Nontreponemal Tests in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Antisera, Control For Nontreponemal Tests (product code GMP). 4 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Antisera, Control For Nontreponemal Tests
- Product code
- GMP
- Country
- United States
Makers of Antisera, Control For Nontreponemal Tests 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 | Contract manufacturer, Manufacturer | 1 | August 19, 1985 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer | 1 | July 6, 1998 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | August 19, 1985 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer, Repackager or relabeler | 1 | July 6, 1998 | 0 | 0 | 0 | api.fda.gov |
| Cenogenics Corp. | Morganville, NJ, United States | Manufacturer | 0 | 0 | 0 | 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.