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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device test, factor ii g20210a mutations, genomic dna pcr
Regulation Description Factor V Leiden DNA mutation detection systems.
Definition In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Product CodeNPR
Regulation Number 864.7280
Device Class 2


Premarket Reviews
ManufacturerDecision
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate test results 1
Improper device output 1
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Operations, Inc. II Mar-14-2011

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