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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, factor v leiden mutations, genomic dna pcr
Regulation Description Factor V Leiden DNA mutation detection systems.
Definition In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Product CodeNPQ
Regulation Number 864.7280
Device Class 2


Premarket Reviews
ManufacturerDecision
Cepheid
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ROCHE DIAGNOSTICS CORP.
  CLEARED FOR MARKETING AUTOMATIC CLASS III DESIGNAT 1

Device Problems
Fracture 1
Oversensing 1
Ambient noise issue 1
Total Device Problems 3

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 0 1 0 2 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Corp. II Jun-22-2007
2 Roche Diagnostics Operations, Inc. II Mar-14-2011
3 Roche Molecular Systems, Inc. II Jun-14-2011
4 Synthes Spine II Feb-03-2009
5 Zimmer, Inc. II Nov-06-2012

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