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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device test, immunity, cell mediated, mycobacterium tuberculosis
Product CodeNCD
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
2 1 0 3 3 1 0 4 0 1

Device Problems
False positive result 17
Nonstandard device or device component 6
Incorrect or inadequate result 4
Total Device Problems 27

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

Recalls
Manufacturer Recall Class Date Posted
1 Cellestis Inc II Feb-26-2013
2 Qiagen Sciences LLC II Mar-22-2016

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