Antisera, All Types, Shigella Spp.
6 catalogue numbers from R30164201, listed by Remel Europe Ltd, United Kingdom, under Antisera, All Types, Shigella Spp. 1 manufacturer in China is registered for this product code.
1manufacturer
6catalogue 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 | Remel Europe Ltd, United Kingdom |
|---|---|
| FDA product code | GNB |
| Device type | Antisera, All Types, Shigella Spp. |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3660 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K895461 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R30164201 | In distribution | |
| R30163801 | In distribution | |
| R30164001 | In distribution | |
| R30858401 | In distribution | |
| R30164101 | In distribution | |
| R30163701 | In distribution |
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 |
| EZ-Shigella One-Step Shigella species Rapid Test | Biomerica | 2 |
| 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.