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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gram-positive bacteria and their resistance markers
Regulation Description Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
Definition A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
Product CodePAM
Regulation Number 866.3365
Device Class 2

Device Problems
False positive result 1
No Known Device Problem 1
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 3 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 BioFire Diagnostics, Inc. II Jun-20-2014
2 Nanosphere, Inc. II Sep-30-2014
3 Nanosphere, Inc. II Sep-23-2014

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