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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 test, hepatitis b (b core, be antigen, be antibody, b core igm)
Product CodeLOM
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
22 22 49 46 124 127 46 46 38 21

Device Problems
False positive result 63
No Known Device Problem 45
False negative result 38
Defective item 16
Incorrect or inadequate test results 14
High test results 11
Other (for use when an appropriate device code cannot be identified) 4
Mechanical issue 4
Low test results 3
Low readings 1
Incorrect or inadequate result 1
Sensitivity 1
Unknown (for use when the device problem is not known) 1
Electrical issue 1
Total Device Problems 203

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