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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device immunohistochemistry assay, antibody, anaplastic lymphoma kinase
Definition The anaplastic lymphoma kinase (ALK) antibody is a qualitative immunohistochemical antibody intended to identify ALK protein expression in human clinical tissue specimens. The ALK antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Product CodePKW
Device Class 3

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

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