Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
The Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement (ALK FISH kit) is an in vitro diagnostic device used to detect rearrangements involving the ALK gene in formalin-fixed, paraffin-embedded non-small cell lung cancer tissue specimens. Results are used to aid in the selection of patients for treatment with specific FDA-approved therapeutic drugs. It is classified as Class 3 (FDA Class 3), requiring Premarket Approval (PMA), with product code OWE, reviewed under the pathology panel.
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Basic Information
- Product Code
- OWE
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- PA
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.