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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device p2psa
Definition Quantitative determination of [-2]proPSA antigen in human serum to be used in combination with total PSA and free PSA to calculate the Prostate Health Index (phi)
Product CodeOYA
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 2 6 4 2 0 5 1 3 4 0 1 0 0

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter, Inc. II Jun-30-2023
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