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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fibrinogen and fibrin split products, antigen, antiserum, control
Regulation Description Fibrinogen/fibrin degradation products assay.
Product CodeDAP
Regulation Number 864.7320
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 3
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 4
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 3
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 5
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1

Device Problems
Low test results 9
Incorrect or inadequate test results 8
High test results 3
Imprecision 2
False negative result 1
Total Device Problems 23

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

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. I Jul-06-2012
2 Siemens Healthcare Diagnostics, Inc. III Aug-28-2012

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