FDA product code QVB

Biological Sterilization Indicator With Indirect Growth Detection

General Hospital·Class 2·21 CFR 880.2806
US regulatory classifications
US Product Code (FDA)
QVB
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 880.2806
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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 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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About this record

Biological Sterilization Indicator With Indirect Growth Detection 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.