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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hepatitis viral b dna detection
Definition Nucleic acid assay for detection of Hepatitis B Virus (HBV) DNA is an in vitro nucleic acid assay for detection and quantitation of HBV DNA in human serum or plasma. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.
Product CodeMKT
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013
0 2 0 2 3 8 5

Device Problems
False positive result 1
Total Device Problems 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 0 0 0 1 0 0
Class III 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular III Feb-23-2011
2 Medtronic Emergency Response Systems, Inc. II Aug-04-2007
3 Roche Molecular Systems, Inc. II Mar-01-2011

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