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Biological Sterilization Process Indicator With Recombinant-Dna Plasmid

FDA product code OWP · 4 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.2805
Review panel
HO
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-03-24 – 2018-06-13

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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