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Antisera, All Types, Shigella Spp.

FDA product code GNB · Class 2 · Microbiology

134
Registered devices
1
Adverse events
3
Recalls
41
510(k) clearances

Devices with this code

Mast Assure Antisera — MAST GROUP LIMITEDMast Assure — MAST GROUP LIMITEDMast Assure Antisera — MAST GROUP LIMITEDBD Difco™ Shigella Antiserum Poly Group C1 S. boydii Serotypes 8–13 — BECTON, DICKINSON AND COMPANYMast Assure — MAST GROUP LIMITEDMast Assure — MAST GROUP LIMITEDMast Assure Antisera — MAST GROUP LIMITEDNA — HARDY DIAGNOSTICSPolyvalent Shigella Slide Antisera - flexneri 1-6 X & Y — PRO-LAB, INCORPORATEDMast Assure — MAST GROUP LIMITEDMast Assre — MAST GROUP LIMITEDNA — HARDY DIAGNOSTICSMast Assure Antisera — MAST GROUP LIMITEDNA — HARDY DIAGNOSTICSNA — HARDY DIAGNOSTICSBD Difco™ Shigella Antiserum Poly Group C S. boydii Serotypes 1–7 — BECTON, DICKINSON AND COMPANYMast Assure Antisera — MAST GROUP LIMITEDMast Assure Antisera — MAST GROUP LIMITEDMast Assure Antisera — MAST GROUP LIMITEDPolyvalent Shigella Slide Antisera - dysenteriae 1-10 — PRO-LAB, INCORPORATEDNA — HARDY DIAGNOSTICSNA — REMEL EUROPE LIMITEDMast Assure Antisera — MAST GROUP LIMITEDNA — HARDY DIAGNOSTICS

Recent recalls

DateFirmReason
2017-12-08Remel IncThe serum may fail to agglutinate within the specified minimum reaction time.
2007-11-30Becton Dickinson & Co.In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.
2007-11-30Becton Dickinson & Co.In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.

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