Data / Medical devices / Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. (GNC): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. (product code GNC, 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 60 510(k) clearances under this code, the latest on August 25, 1997, and lists 2 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- GNC
- Device class
- 2
- Regulation
- 866.3550
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| India | 1 |
| United Kingdom | 1 |
Makers of Antigens, Febrile, Slide And Tube, 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 |
|---|---|---|---|---|---|---|---|---|
| Cenogenics Corp. | Morganville, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer, Repackager or relabeler | 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 | |
| Lumiquick Diagnostics, Inc. | Santa Clara, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lords Mark Industries Ltd. | Daman and Diu Dadra and Nagar Haveli, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 25, 1997. 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.