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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device assay, t lymphocyte surface marker
Regulation Description Automated differential cell counter.
Product CodeLIZ
Regulation Number 864.5220
Device Class 2


Premarket Reviews
ManufacturerDecision
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1

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 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Becton, Dickinson and Company, BD Biosciences III Nov-04-2015

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