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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
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


Premarket Reviews
ManufacturerDecision
VERIDEX, LLC
  SUBSTANTIALLY EQUIVALENT 5
  1.  K103502  CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 790000 ...
  2.  K110406  CELLTRACKS AUTOPREP SYSTEM
  3.  K113181  CELLTRACKS ANALYER II
  4.  K122821  CELLTRACKS AUTOPREP SYSTEM
  5.  K130794  CELLTRACKS ANALYZER II SYSTEM

Recalls
Manufacturer Recall Class Date Posted
1 Menarini Silicon Biosystems II Jul-07-2022
2 Menarini Silicon Biosystems II Apr-26-2018
3 Veridex, LLC II Aug-18-2015
4 Veridex, LLC II Mar-13-2014
5 Veridex, LLC II Aug-10-2013
6 Veridex, LLC II Feb-13-2012
7 Veridex, LLC II Feb-23-2010
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