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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, rna detection, human papillomavirus
Definition For the detection of human papillomavirus RNA to aid in assessing risk of cancer.
Product CodeOYB
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 1 1 2 3 7 6 4 12 14 9 0 3 3 0

MDR Year MDR Reports MDR Events
2016 1 1
2017 1 1
2018 2 2
2021 3 3
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 2 2
Output Problem 2 2
Erratic Results 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Chemical Spillage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Test Result 2 2
Hypoglycemia 1 1
Chemical Exposure 1 1

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