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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen
Regulation Description Antimicrobial susceptibility test powder.
Definition A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.
Product CodeNQX
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
Cepheid
  SUBSTANTIALLY EQUIVALENT 7
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 1 0 0 0 0 0 0
Class II 0 1 1 0 1 1 0 1 0 1
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 BD Diagnostics (GeneOhm Sciences, Inc) II Sep-10-2009
2 BD Diagnostics (GeneOhm Sciences, Inc) II Oct-31-2008
3 Becton Dickinson & Co. II Sep-10-2014
4 Becton Dickinson & Co. II Sep-06-2012
5 Becton Dickinson & Co. II Sep-16-2011
6 Cepheid II Aug-16-2016
7 Cepheid III Jan-11-2012
8 Cepheid I Jul-01-2010

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