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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 2 6 9 17 7 8 16 13 29 28 14 9 9 16 4

MDR Year MDR Reports MDR Events
2014 2 2
2017 1 1
2018 1 1
2019 1 1
2022 2 2
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Non Reproducible Results 2 2
False Reading From Device Non-Compliance 1 1
High Readings 1 1
Device Operates Differently Than Expected 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Exposure to Body Fluids 1 1
Test Result 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular III Feb-23-2011
2 Abbott Molecular, Inc. II Apr-06-2022
3 Roche Diagnostics Operations, Inc. II Oct-25-2016
4 Roche Molecular Systems, Inc. II Mar-01-2011
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