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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device assay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Product CodeMZP
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
5 12 11 19 20 17 24 12 12 19

Device Problems
False negative result 2
Incorrect or inadequate result 1
High test results 1
Foreign material present in device 1
Total Device Problems 5

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