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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device respiratory panel
Regulation Description Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
Definition The panel is a multiplexed nucleic acid test intended for use with systems for the simultaneous detection and identification of multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals suspected of lower respiratory tract infection.
Product CodeQDP
Regulation Number 866.3985
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOFIRE DIAGNOSTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

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