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 Code | OWE |
Device Class |
3
|
Premarket Approvals (PMA) |
2019 |
2020 |
2021 |
2022 |
2023 |
2024 |
2
|
2
|
0
|
0
|
0
|
0
|
|
|
|