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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
Definition Anaplastic lymphoma kinase (ALK) fluorescence in situ hybridization (FISH) kit is to detect rearrangements involving the ALK gene in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens. It is indicated to aid in the selection of patients for treatment with specific FDA approved therapeutic drugs.
Product CodeOWE
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 2 2 4 1 3 2 3 2 2 0 0 0 0

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Damaged Prior to Use 2 2
False Negative Result 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 1 1

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