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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 2017
22 22 49 46 124 127 46 46 38 46 1

Device Problems
No Known Device Problem 83
False positive result 67
False negative result 42
Incorrect or inadequate test results 21
High test results 16
Defective item 16
Low test results 8
Mechanical issue 5
Other (for use when an appropriate device code cannot be identified) 4
Unknown (for use when the device problem is not known) 1
Electrical issue 1
Incorrect or inadequate result 1
Sensitivity 1
Low readings 1
Total Device Problems 267

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