OWP

Biological Sterilization Process Indicator With Recombinant-Dna Plasmid

Product code

OWP

Device name

Biological Sterilization Process Indicator With Recombinant-Dna Plasmid

Device class

Class 2

21 CFR

21 CFR 880.2805

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).