# Immunohistochemical Assay, Helicobacter Pylori
> **Product code: OWF** · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3110
## Classification
- **FDA Product Code:** OWF
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 866.3110
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

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

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OWF)
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