FDA product code OWP

Biological Sterilization Process Indicator With Recombinant-Dna Plasmid

General Hospital·Class 2·21 CFR 880.2805
US regulatory classifications
US Product Code (FDA)
OWP
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 880.2805
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Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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Biological Sterilization Process Indicator With Recombinant-Dna Plasmid is a medical device type in the General Hospital specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.