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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthopedic infection microbial multiplex nucleic acid detection system
Definition A qualitative nucleic acid assay that detects and identifies microbial organisms and antimicrobial resistance markers in clinical specimens to aid in the diagnosis of orthopedic infections.
Product CodeQSN
Regulation Number 866.3988
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOFIRE DIAGNOSTICS, LLC
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