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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, immunomagnetic, circulating cancer cell, enumeration
Regulation Description Immunomagnetic circulating cancer cell selection and enumeration system.
Definition In vitro diagnostic device to aid in the enumeration of immunomagnetically selected and fluorescently identified circulating tumor cells of epithelial origin in whole blood for prediction of cancer progression and survival.
Product CodeNQI
Regulation Number 866.6020
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 1 0 1 1 1 1 0
Class III 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Veridex, LLC II Aug-18-2015
2 Veridex, LLC II Mar-13-2014
3 Veridex, LLC II Aug-10-2013
4 Veridex, LLC II Feb-13-2012
5 Veridex, LLC II Feb-23-2010
6 Veridex, LLC III Jul-24-2007

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