| 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. |
| Physical State |
Probe and accessory assay kits contains pre-treatment solution, ALK dual color break apart probe mix, buffers, counter stain, and fluorescence mounting medium |
| Technical Method |
Fluorescence in situ hybridization, manual method |
| Target Area |
Formalin-fixed, paraffin-embedded human non-small cell lung cancer tissue specimen |
| Review Panel |
Immunology |
|---|
| Product Code | OWE |
|---|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
