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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, test, infectious mononucleosis
Regulation Description Infectious mononucleosis immunological test system.
Product CodeKTN
Regulation Number 866.5640
Device Class 2


Premarket Reviews
ManufacturerDecision
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
GAMMA
  SUBSTANTIALLY EQUIVALENT 2
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 2
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 2
TRINITY
  SUBSTANTIALLY EQUIVALENT 1
UNIPATH
  SUBSTANTIALLY EQUIVALENT 2
WAMPOLE LABORATORIES,LLC
  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 1 0 0 1

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. III Jul-22-2016
2 Alere San Diego, Inc. III Apr-18-2013

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