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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device rt-pcr multigene expression test, sentinel lymph node, cancer metastasis detection
Definition A gene expression test for detection of cancer metastasisis an in vitro diagnostic test performed on tissue of interest from patients previously diagnosed with cancer. Results from the test can be used to guide the intra-operative or post-operative decision to remove additional tissue. Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using an appropriate histological sampling scheme, is required.
Product CodeOCB
Device Class 3

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

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