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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device giardia spp.
Regulation Description Entamoeba histolyticaserological reagents.
Product CodeMHI
Regulation Number 866.3220
Device Class 2


Premarket Reviews
ManufacturerDecision
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
REMEL INC
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
TRINITY
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Remel, Inc II Sep-19-2008

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