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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lower respiratory microbial nucleic acid detection system
Regulation Description Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
Definition Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
Product CodeQBH
Regulation Number 866.3985
Device Class 2


Premarket Reviews
ManufacturerDecision
CURETIS GMBH
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 BioFire Diagnostics, LLC II Jul-08-2021
2 BioFire Diagnostics, LLC II Jun-24-2021
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