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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mass spectrometry, microorganism identification, blood culture
Definition Blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system with organisms subsequently identified by spectrometry.
Product CodeQNJ
Regulation Number 866.3378
Device Class 2


Premarket Reviews
ManufacturerDecision
BRUKER DALTONIK GMBH
  SUBSTANTIALLY EQUIVALENT 1

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