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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device micro total analysis instrument system
Regulation Description Instrumentation for clinical multiplex test systems.
Definition A micro total analysis instrument system is a clinical multiplex instrument intended to measure and sort signals generated by fluorescently-labeled immune complexes from a clinical sample on a microcapillary chip. Signals may be quantified using laser-induced-fluorescence detection using filters on a photodiode or other detector. It may integrate microfluidic chips with discrete zones for clinical sample and assay reagents; capillary electrophoresis; reagent handling system; dedicated instrument control; data acquisition software; raw data storage mechanisms; and other essential hardware components and signal reader unit. It is used with specific assays to comprise an assay test system.
Product CodeOUE
Regulation Number 862.2570
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 0 0 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Leica Microsystems, Inc. II Jun-07-2014

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