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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device multiplex nucleic acid detection system for biothreat agents
Definition A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens
Product CodeQVR
Regulation Number 866.4000
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOFIRE DEFENSE, LLC
  SUBSTANTIALLY EQUIVALENT 1
T2 BIOSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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