Immunohistochemical Assay, Helicobacter Pylori
Microbiology · 21 CFR 866.3110
Anti-helicobacter pylori rabbit monoclonal primary antibody is designed to qualitatively detect the presence of helicobacter pylori in formalin-fixed, paraffin-embedded gastric biopsy tissue via light microscopy. Immunohistochemical staining with this antibody product may aid in the diagnosis of helicobacter pylori infection. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls. This antibody is intended for in vitro diagnostic (IVD) use
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Ventana Medical Systems IncTerminatedSep 14, 2018
VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Z-3010-2018 · View FDA record ↗ - Cell Marque CorporationTerminatedJun 1, 2017
H. pylori (polyclonal}
Cell 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 Export Only" as required by section 801 (e )(1) of the FD&C Act.
Z-2202-2017 · View FDA record ↗
Registered firms
3 firms currently registered for this product code
510(k) clearances
1 clearances for this product code