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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system,test,antibodies,b2 - glycoprotein i (b2 - gpi)
Regulation Description Multiple autoantibodies immunological test system.
Product CodeMSV
Regulation Number 866.5660
Device Class 2


Premarket Reviews
ManufacturerDecision
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0


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