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) → OZA — Test, Urea Adult And Pediatric (Breath),

# OZA · Test, Urea Adult And Pediatric (Breath),

_Microbiology · 21 CFR 866.3110 · Class 3_

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

## Overview

- **Product Code:** OZA
- **Device Name:** Test, Urea Adult And Pediatric (Breath),
- **Regulation:** [21 CFR 866.3110](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3110)
- **Device Class:** 3
- **Review Panel:** [Microbiology](/submissions/MI)

## 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P170022](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZA/P170022.md) | PyloPlus UBT System | Arj Medical, Inc. | Feb 18, 2020 | APPR |
| [P100025](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZA/P100025.md) | BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0 | Meridian Bioscience, Inc. | Feb 22, 2012 | APWD |

## Top Applicants

- Arj Medical, Inc. — 1 clearance
- Meridian Bioscience, Inc. — 1 clearance

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

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