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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device microscope,automated,image analysis,immunohistochemistry,operator intervention,nuclear intensity & percent positivity
Regulation Description Immunohistochemistry reagents and kits.
Definition Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.
Product CodeNQN
Regulation Number 864.1860
Device Class 2


Premarket Reviews
ManufacturerDecision
TRIPATH IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 3
Ventana Medical Systems Inc
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Fluid leak 1
Total Device Problems 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Leica Biosystems Richmond Inc. III Jun-10-2016
2 Leica Microsystems, Inc. II Mar-24-2009
3 Ventana Medical Systems Inc II Mar-18-2008

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