Data / Medical devices / Antisera, Control For Nontreponemal Tests
Antisera, Control For Nontreponemal Tests (GMP): 5 FDA-registered makers in 1 country
5 establishments in 1 country are registered with the FDA to make Antisera, Control For Nontreponemal Tests (product code GMP, Class 2, 21 CFR 866.3820). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on July 6, 1998, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GMP
- Device class
- 2
- Regulation
- 866.3820
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
Makers of Antisera, Control For Nontreponemal Tests
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 | 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 July 6, 1998. 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.