# Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
> **Product code: OWP** · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.2805
## Classification
- **FDA Product Code:** OWP
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 880.2805
- **Review panel:** HO
- **Medical specialty:** General Hospital
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

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.

## Market data
- **Cleared 510(k) submissions:** 5
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OWP)
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