Data / Medical devices / Antisera, All Groups, Salmonella Spp.
Antisera, All Groups, Salmonella Spp. (GRM): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Antisera, All Groups, Salmonella Spp. (product code GRM, Class 2, 21 CFR 866.3550). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 69 510(k) clearances under this code, the latest on June 18, 1996, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GRM
- Device class
- 2
- Regulation
- 866.3550
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| United Kingdom | 2 |
| China | 1 |
| Mexico | 1 |
| Australia | 1 |
| Denmark | 1 |
Makers of Antisera, 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 |
|---|---|---|---|---|---|---|---|---|
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Manufacturer | 1 | February 16, 1989 | 0 | 1 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Genesee Biotech, Inc. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerica De Mexico, S.A. De C.V. | MEXICALI Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centers For Disease Control And Prevention | Atlanta, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genbio | San Diego, 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 | |
| Keva Inc. | Blaine, WA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lee Laboratories, Inc. | Grayson, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oxoid Australia Pty Limited | THEBARTON South Australia, Australia | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oxoid, Ltd. | Basingstoke, Hampshire, United Kingdom | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SSI Diagnostica A/S | Hilleroed Hovedstaden, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 18, 1996. 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.