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Antisera, All Types, Shigella Spp.
FDA product code GNB · Class 2 · Microbiology
133
Registered devices
1
Adverse events
3
Recalls
41
510(k) clearances
Devices with this code
Shigella sonnei Fase I serum, 3 mL — Ssi Diagnostica A/SMast Assure Antisera — MAST GROUP LIMITEDNA — HARDY DIAGNOSTICSMast Assure Antisera — MAST GROUP LIMITEDNA — HARDY DIAGNOSTICSNA — HARDY DIAGNOSTICSMast Assure Antisera — MAST GROUP LIMITEDPolyvalent Shigella Slide Antisera - flexneri 1-6 X & Y — PRO-LAB, INCORPORATEDNA — HARDY DIAGNOSTICSMast Assure — MAST GROUP LIMITEDMast Assure — MAST GROUP LIMITEDMast Assure — MAST GROUP LIMITEDNA — REMEL EUROPE LIMITEDNA — HARDY DIAGNOSTICSNA — REMEL EUROPE LIMITEDNA — HARDY DIAGNOSTICSShigella sonnei Fase II serum, 3 mL — Ssi Diagnostica A/SBD Difco™ Shigella Antiserum Poly Group C1 S. boydii Serotypes 8–13 — BECTON, DICKINSON AND COMPANYNA — REMEL EUROPE LIMITEDNA — HARDY DIAGNOSTICSMast Assure — MAST GROUP LIMITEDShigella Antisera Set 2 — MAST GROUP LIMITEDMast Assure Antisera — MAST GROUP LIMITEDNA — HARDY DIAGNOSTICS
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-08 | Remel Inc | The serum may fail to agglutinate within the specified minimum reaction time. |
| 2007-11-30 | Becton Dickinson & Co. | In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results. |
| 2007-11-30 | Becton Dickinson & Co. | In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results. |
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