Data / Medical devices / Antigens, All, Leptospira Spp. / United States
FDA-registered makers of Antigens, All, Leptospira Spp. in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Antigens, All, Leptospira Spp. (product code GRY). 1 has 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, All, Leptospira Spp.
- Product code
- GRY
- Country
- United States
Makers of Antigens, All, Leptospira Spp. in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Genbio | San Diego, CA, United States | Manufacturer | 1 | November 22, 2000 | 0 | 0 | 0 | api.fda.gov |
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VMRD, Inc. | Fullerton, 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.