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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)
2021 2022 2023 2024 2025 2026
0 0 0 0 1 1

MDR Year MDR Reports MDR Events
2024 2 2

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

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