Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart C — General Hospital and Personal Use Monitoring Devices](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices) → [21 CFR 880.2805](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2805) → OWP — Biological Sterilization Process Indicator With Recombinant-Dna Plasmid

# OWP · Biological Sterilization Process Indicator With Recombinant-Dna Plasmid

_General Hospital · 21 CFR 880.2805 · Class 2_

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

## Overview

- **Product Code:** OWP
- **Device Name:** Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
- **Regulation:** [21 CFR 880.2805](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2805)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## 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.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K181442](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/OWP/K181442.md) | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | Jun 13, 2018 | SESE |
| [K162945](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/OWP/K162945.md) | VERIFY ASSERT STEAM Process Challenge Device | STERIS Corporation | Apr 28, 2017 | SESE |
| [K163587](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/OWP/K163587.md) | VERIFY Incubator for Assert Self Contained Biological Indicators | STERIS Corporation | Mar 24, 2017 | SESE |
| [K162701](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/OWP/K162701.md) | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | Mar 24, 2017 | SESE |
| [DEN110006](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/OWP/DEN110006.md) | VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR | STERIS Corporation | Jul 12, 2013 | DENG |

## Top Applicants

- STERIS Corporation — 5 clearances

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

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