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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device test, system, immunoassay, lipoprotein-associated phospholipase a2
Regulation Description Low-density lipoprotein immunological test system.
Definition The Lipoprotein-associated Phospholipase A2, Immunoassay, System, Test, is intended to measure lipoprotein-associated phospholipase A2 in human plasma in conjunction with clinical evaluation and other patient risk factors including biochemical analyses as an aid in predicting risk for coronary heat disease. This device differs from the classification regulation in that it is a different analyte, thus a NEW marker for predicting risk of coronary heart disease. This device is measuring an enzyme that is produced by macrophages where as the regulation is for the measurement of a lipoprotein.
Product CodeNOE
Regulation Number 866.5600
Device Class 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 1 2 2 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 DiaDexus, Inc II Mar-21-2011
2 DiaDexus, Inc II Nov-22-2010
3 DiaDexus, Inc II Jun-03-2010
4 DiaDexus, Inc II Apr-23-2009
5 DiaDexus, Inc II Apr-01-2009
6 DiaDexus, Inc II Sep-26-2008

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