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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device plasma, coagulation factor deficient
Regulation Description Factor deficiency test.
Product CodeGJT
Regulation Number 864.7290
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 5
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 8
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
PACIFIC HEMOSTASIS
  SUBSTANTIALLY EQUIVALENT 2

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

Recalls
Manufacturer Recall Class Date Posted
1 Diagnostica Stago, Inc. II Mar-14-2013

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