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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device assay,enzyme linked immunosorbent,hepatitis c virus
Product CodeMZO
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
5 3 11 12 40 24 16 10 14 19 12

Device Problems
False negative result 132
Low test results 32
No Known Device Problem 26
False positive result 16
Defective item 15
Incorrect or inadequate test results 12
Mechanical issue 12
High test results 4
No Information 2
Spillage, accidental 1
Total Device Problems 252

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