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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device control material, blood circulating epithelial cancer cell
Regulation Description Hematology quality control mixture.
Definition The Epithelial Cell Control Kit contains two levels of fixed cells that are stained with a fluorescence marker and are used to verify sample processing and cell analysis of circulating tumor cells. This device is used as an assay quality control to ensure that sample detection and identification systems are able to detect circulating epithelial tumor cells.
Product CodeNRS
Regulation Number 864.8625
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 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Veridex, LLC III Mar-01-2011

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