Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3110](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3110) → OWF — Immunohistochemical Assay, Helicobacter Pylori

# OWF · Immunohistochemical Assay, Helicobacter Pylori

_Microbiology · 21 CFR 866.3110 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OWF

## Overview

- **Product Code:** OWF
- **Device Name:** Immunohistochemical Assay, Helicobacter Pylori
- **Regulation:** [21 CFR 866.3110](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3110)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)
- **3rd-party reviewable:** yes

## Identification

Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases. Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.

## Classification Rationale

Class I (general controls).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K101234](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OWF/K101234.md) | VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | Aug 25, 2011 | SESE |

## Top Applicants

- Ventana Medical Systems, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OWF](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OWF)

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