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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device assay, nucleic acid amplification, bacillus anthracis
Regulation Description Microorganism differentiation and identification device.
Definition An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.
Product CodeNHT
Regulation Number 866.2660
Device Class 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 0 0 0
Class III 0 0 0 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biofire Defense III Sep-15-2014

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