← Product Code [OWP](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/OWP) · DEN110006

# VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR (DEN110006)

_STERIS Corporation · OWP · Jul 12, 2013 · General Hospital · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/OWP/DEN110006

## Device Facts

- **Applicant:** STERIS Corporation
- **Product Code:** [OWP](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/OWP.md)
- **Decision Date:** Jul 12, 2013
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 880.2805
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/OWP/DEN110006](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/OWP/DEN110006)

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