Antisera, All Types, Shigella Spp.
Shigella flexneri group (3)4 antiserum, 2ml
1manufacturer
56catalogue 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 | Hardy Diagnostics, United States |
|---|---|
| FDA product code | GNB |
| Device type | Antisera, All Types, Shigella Spp. |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3660 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-03-28 |
| Record revised | 2021-01-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2018-09-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 295217 | In distribution | |
| 295033 | Withdrawn | |
| 295309 | Withdrawn | |
| 295286 | Withdrawn | |
| 295330 | Withdrawn | |
| 294982 | Withdrawn | |
| 294999 | Withdrawn | |
| 295248 | Withdrawn | |
| 294876 | Withdrawn | |
| 294944 | Withdrawn | |
| 295064 | Withdrawn | |
| 295194 | Withdrawn | |
| 294968 | Withdrawn | |
| 295118 | Withdrawn | |
| 294883 | Withdrawn | |
| 294975 | Withdrawn | |
| 295002 | Withdrawn | |
| 295149 | Withdrawn | |
| 294920 | Withdrawn | |
| 295026 | Withdrawn | |
| 295224 | Withdrawn | |
| 295125 | Withdrawn | |
| 295293 | Withdrawn | |
| 295088 | Withdrawn | |
| 294951 | Withdrawn | |
| 295255 | Withdrawn | |
| 294906 | Withdrawn | |
| 294845 | Withdrawn | |
| 295170 | Withdrawn | |
| 294821 | Withdrawn | |
| 294890 | Withdrawn | |
| 294890 | Withdrawn | |
| 294937 | Withdrawn | |
| 295279 | Withdrawn | |
| 295088 | Withdrawn | |
| 295316 | Withdrawn | |
| 295323 | Withdrawn | |
| 295231 | Withdrawn | |
| 295132 | Withdrawn | |
| 294913 | Withdrawn | |
| 295231 | Withdrawn | |
| 294852 | Withdrawn | |
| 295101 | Withdrawn | |
| 295156 | Withdrawn | |
| 294982 | Withdrawn | |
| 295057 | Withdrawn | |
| 294869 | Withdrawn | |
| 295309 | Withdrawn | |
| 295187 | Withdrawn | |
| 295071 | Withdrawn | |
| 295019 | Withdrawn | |
| 294838 | Withdrawn | |
| 295040 | Withdrawn | |
| 295200 | Withdrawn | |
| 295262 | Withdrawn | |
| 295163 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mast Assure Antisera | Mast Group Ltd. | 31 |
| Mast Assure | Mast Group Ltd. | 17 |
| Antisera, All Types, Shigella Spp. | Remel Europe Ltd | 6 |
| 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.