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Biological Sterilization Indicator With Indirect Growth Detection

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.

Global Registration Data
Multi-Country Intelligence
Biological Sterilization Indicator With Indirect Growth Detection
General Hospital Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QVB

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Class 2

21 CFR 880.2806

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General Hospital

Device Characteristics

No

No

No

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.