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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reagent, russel viper venom
Regulation Description Russell viper venom reagent.
Product CodeGIR
Regulation Number 864.8950
Device Class 1


Premarket Reviews
ManufacturerDecision
DIAGNOSTICA STAGO
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 2

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 1 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 American Diagnostica, Inc. II May-03-2007

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