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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device antibody igm,if, cytomegalovirus virus
Regulation Description Cytomegalovirus serological reagents.
Product CodeLKQ
Regulation Number 866.3175
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High test results 3
Device ingredient or reagent issue 1
No Known Device Problem 1
False positive result 1
Incorrect or inadequate result 1
Total Device Problems 7

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Jul-11-2007
2 QIAGEN Gaithersburg, Inc. II May-14-2013
3 Quest International, Inc. III Jan-23-2012

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