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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)
2019 2020 2021 2022 2023 2024
14 9 0 3 3 0

MDR Year MDR Reports MDR Events
2021 3 3
2022 1 1

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4

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