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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 3

Device Problems
False negative result 131
Low test results 26
No Known Device Problem 21
Defective item 15
False positive result 15
Incorrect or inadequate test results 11
High test results 4
Mechanical issue 1
Spillage, accidental 1
Total Device Problems 225

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