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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mycobacterium tuberculosis, cell mediated immune response, enzyme-linked immunospot test
Definition For the detection of effector T cells that respond to stimulation by Mycobacterium tuberculosis antigens ESAT-6 and CFP-10 and indicated for use as an aid in the diagnosis of M. tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.
Product CodeOJN
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 1 1 3 2 2 2 0 0 0

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