← Product Code [MSQ](/submissions/MI/subpart-d%E2%80%94serological-reagents/MSQ) · K000316

# MERETEK UBT_LITE BREATH TEST FOR H. PYLORI (K000316)

_Meretek · MSQ · Feb 24, 2000 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MSQ/K000316

## Device Facts

- **Applicant:** Meretek
- **Product Code:** [MSQ](/submissions/MI/subpart-d%E2%80%94serological-reagents/MSQ.md)
- **Decision Date:** Feb 24, 2000
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.3110
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MSQ/K000316](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MSQ/K000316)

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