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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
Definition Anaplastic lymphoma kinase (ALK) fluorescence in situ hybridization (FISH) kit is to detect rearrangements involving the ALK gene in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens. It is indicated to aid in the selection of patients for treatment with specific FDA approved therapeutic drugs.
Product CodeOWE
Device Class 3

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

Device Problems
False negative result 1
Total Device Problems 1

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