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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device biological sterilization indicator with indirect growth detection
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.
Product CodeQVB
Regulation Number 880.2806
Device Class 2


Premarket Reviews
ManufacturerDecision
TERRAGENE SA
  GRANTED 1

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