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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device multi-analyte test system with algorithmic analysis for detection of prostate cancer
Definition Test system that combines values from multiple assays with/without other patient information to yield a score value for aid in detection of prostate cancer and/or decision for prostate biopsy.
Product CodeQRF
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
0 0 1 0 0 2

MDR Year MDR Reports MDR Events
2023 371 371

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Version or Upgrade Problem 371 371

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 371 371

Recalls
Manufacturer Recall Class Date Posted
1 BioReference Health, LLC II Dec-08-2023
2 BioReference Health, LLC II Jun-02-2023
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