EZ-Shigella One-Step Shigella Species Rapid Test
The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella species in human stool samples. The test is intended for…
The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella 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 Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Tianlong Biotechnology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Biomerica, United States |
|---|---|
| FDA product code | GNB |
| Device type | Antisera, All Types, Shigella Spp. |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3660 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-01-10 |
| Record revised | 2021-09-02 (version 2) |
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 |
|---|---|---|
| 1009-15 | In distribution | |
| 1009-15 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Antisera, All Types, Shigella Spp. | Hardy Diagnostics | 56 |
| Mast Assure Antisera | Mast Group Ltd. | 31 |
| Mast Assure | Mast Group Ltd. | 17 |
| Antisera, All Types, Shigella Spp. | Remel Europe Ltd | 6 |
| Mastr Assure | Mast Group Ltd. | 1 |
| Polyvalent Shigella Slide Antisera – boydii 1-15 | pro-lab incorporated | 1 |
| BD Difco™ Shigella Antiserum Poly Group B S. flexneri Serotypes 1 → 6 | Becton, Dickinson AND Company | 1 |
| Polyvalent Shigella Slide Antisera – dysenteriae 1-10 | pro-lab incorporated | 1 |
| BD Difco™ Shigella Antiserum Poly Group C2 S. boydii Serotypes 14 → 18 | Becton, Dickinson AND Company | 1 |
| BD Difco™ Shigella Antiserum Poly Group A S. dysenteriae Serotypes 1 → 7 | Becton, Dickinson AND Company | 1 |
| BD Difco™ Shigella Antiserum Poly Group C1 S. boydii Serotypes 8 → 13 | Becton, Dickinson AND Company | 1 |
| Shigella sonnei Fase II serum, 3 mL | SSI Diagnostica A/S | 1 |
Showing 12 of 26. All products under Antisera, All Types, Shigella 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.