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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device epstein-barr virus, other
Regulation Description Epstein-Barr virus serological reagents.
Product CodeLSE
Regulation Number 866.3235
Device Class 1


Premarket Reviews
ManufacturerDecision
DIASORIN
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Use of Incorrect Control Settings 1
Use of Device Issue 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 1 0 1 1 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories II Apr-27-2011
2 Bio-Rad Laboratories II Jun-11-2008
3 Calbiotech Inc II Mar-05-2010
4 Diamedix Corporation II May-16-2016

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