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Biological Sterilization Indicator With Indirect Growth Detection

FDA product code QVB · 2 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.2806
Review panel
HO
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-04-22 – 2026-06-18

A biological sterilization indicator with indirect growth detection capabilities is a device intended for use by a healthcare provider to accompany products being sterilized through a sterilization process to monitor the adequacy of sterilization. Detection of surviving microorganisms is accomplished by a method other than direct detection of growth or growth products.

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