EZ-Salmonella One-Step Salmonella Species Rapid Test
The Biomerica Salmonella test is a lateral flow immunoassay for the rapid determination of the presence of Salmonella species in human stool samples. The test is intended for professional…
The Biomerica Salmonella test is a lateral flow immunoassay for the rapid determination of the presence of Salmonella species in human stool samples. The test is intended for professional use only.
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Genesee Biotech, Inc. | Beijing | Beijing | Manufacturer | 4 |
Record
| Listed by | Biomerica, United States |
|---|---|
| FDA product code | GRM |
| Device type | Antisera, All Groups, Salmonella Spp. |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3550 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-07-01 |
| Record revised | 2022-06-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2020-07-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1007-15 | In distribution | |
| 1007-15 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Antisera, All Groups, Salmonella Spp. | Remel Europe Ltd | 69 |
| Antisera, All Groups, Salmonella Spp. | Hardy Diagnostics | 59 |
| Mast Assure Antisera | Mast Group Ltd. | 31 |
| Mast Assure | Mast Group Ltd. | 15 |
| Monovalent Flagella Salmonella Antisera – Factor z29 | pro-lab incorporated | 10 |
| Monovalent Flagella Salmonella Antisera – Factor enx | pro-lab incorporated | 3 |
| Rapid Polyvalent Salmonella Diagnostic Sera RSD 2 | pro-lab incorporated | 3 |
| BD Difco™ Salmonella O Antiserum Group B Factors 1, 4, 12, 27 | Becton, Dickinson AND Company | 2 |
| Salmonella Sero-Quick Group Kit | SSI Diagnostica A/S | 2 |
| Monovalent Flagella Salmonella Antisera – Factors l, v | pro-lab incorporated | 2 |
| Polyvalent Flagella Salmonella Antisera – H Phase 1 & 2 | pro-lab incorporated | 2 |
| BD Difco™ Salmonella H Antiserum Single Factor z23 | Becton, Dickinson AND Company | 2 |
Showing 12 of 404. All products under Antisera, All Groups, Salmonella Spp.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.