Data / Medical devices / Antigens, All Groups, Salmonella Spp.
Antigens, All Groups, Salmonella Spp. (GRL): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Antigens, All Groups, Salmonella Spp. (product code GRL, Class 2, 21 CFR 866.3550). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on March 7, 1995, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GRL
- Device class
- 2
- Regulation
- 866.3550
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Denmark | 1 |
| China | 1 |
Makers of Antigens, All Groups, Salmonella Spp.
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 |
|---|---|---|---|---|---|---|---|---|
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CTK Biotech, Inc. | Poway, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lee Laboratories, Inc. | Grayson, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SSI Diagnostica A/S | Hilleroed Hovedstaden, Denmark | 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 | |
| Weihai Kangzhou Biotechnology Engineering Co., Ltd. | Weihai Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 7, 1995. 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.