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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, programmed death-ligand 1
Regulation Description Immunohistochemistry reagents and kits.
Definition The programmed death-ligand 1 (PD-L1) antibody is a qualitative immunohistochemical antibody intended to identify PD-L1 protein expression in human clinical tissue specimens. The PD-L1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs or to assess PD-L1 expression level in patients who may respond particularly well to specific FDA approved therapeutic drugs.
Product CodePLS
Regulation Number 864.1860
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 2

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