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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reagents for detection of norovirus nucleic acid
Definition Qualitative in vitro diagnostic test for the rapid detection and differentiation of norovirus genogroup I and genogroup II from specimens e.g., stool collected from individuals with symptoms of acute gastroenteritis.
Product CodePIQ
Regulation Number 866.3990
Device Class 2


Premarket Reviews
ManufacturerDecision
R-BIOPHARM AG
  SUBSTANTIALLY EQUIVALENT 1

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