OWE

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

Product code: OWE
Device name: Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OWE

Classification and pathway per current FDA publications. Data from openFDA (CC0).