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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device automated system for sample preparation and identification of microorganisms from cultured isolates by mass spectrometry
Definition An automated in vitro diagnostic system to prepare colonies of microorganisms grown on solid culture media from human specimens for qualitative identification and differentiation using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS).
Product CodeQQV
Regulation Number 866.3378
Device Class 2


Premarket Reviews
ManufacturerDecision
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
COPAN WASP S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
COPAN WASP SRL
  SUBSTANTIALLY EQUIVALENT 1

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