OWE · Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
· Class 3
Overview
| Product Code | OWE |
|---|---|
| Device Name | Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement |
| Device Class | Class 3 |
| Review Panel |
Identification
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P110012 | VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK | Abbott Molecular, Inc. | Aug 26, 2011 | APPR |
Top Applicants
- Abbott Molecular, Inc. — 1 clearance
