Home › PRO-LAB, INCORPORATED › Polyvalent Shigella Slide Antisera - dysenteriae 1-10
Polyvalent Shigella Slide Antisera - dysenteriae 1-10
PRO-LAB, INCORPORATED · Model PL.6902 · UDI-DI 05060472462732
10
510(k) clearances
1
Adverse events
3
Recalls
7
Facilities
Description
Shigella are differentiated from the closely related Escherichia coli on the basis of pathogenicity, physiology and serology. Pro-Lab polyvalent Shigella antisera are intended to aid in the serological identification after culture, isolation and biochemical characterization of Shigella organisms. These antisera are prepared in rabbits using reference strains according to recognized guidelines, and absorbed to remove cross-reactions. Shigella antisera are supplied in 2.0 ml dropper bottles, in a ready to use format.
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.