OWE — Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement Class III
FDA product code OWE covers "Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OWE
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Unknown
- Implant
- No
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.