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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
Definition In vitro diagnostic test to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus via fluorescence in situ hybridization (fish) in urine specimens from persons suspected of having bladder cancer. It is an adjunctive test for initial diagnosis of transitional cell carcinoma in symptomatic patients and subsequently monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
Product CodeNSD
Device Class 3

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

MDR Year MDR Reports MDR Events
2014 1 1
2015 2 2
2016 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Device Damaged Prior to Use 2 2
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 2 2
No Consequences Or Impact To Patient 1 1

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