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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, mass spectrometry, maldi tof, microorganism identification, cultured isolates
Definition A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.
Product CodePEX
Regulation Number 866.3361
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMERIEUX
  GRANTED 1

Device Problems
Incorrect or inadequate result 26
Incorrect or inadequate test results 4
False device output 1
Total Device Problems 31

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