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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 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)
2020 2021 2022 2023 2024 2025
14 9 9 16 18 0

MDR Year MDR Reports MDR Events
2022 2 2
2023 2 2
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 2 2
Low Test Results 2 2
Adverse Event Without Identified Device or Use Problem 1 1
High Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular, Inc. II Apr-06-2022
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