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Immunohistochemical Assay, Helicobacter Pylori

FDA product code OWF · Class 1 · Microbiology

2
Registered devices
1
Adverse events
2
Recalls
1
510(k) clearances

Devices with this code

VENTANA antiHelicobacter pylori SP48 Rabbit Monoclonal Primary Antibody — Ventana Medical Systems, Inc.VENTANA antiHelicobacter pylori SP48 Rabbit Monoclonal Primary Antibody — Ventana Medical Systems, Inc.

Recent recalls

DateFirmReason
2018-08-02Ventana Medical Systems IncLeaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
2017-05-05Cell Marque CorporationCell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Ex

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.