PKW
- Product code
- PKW
- Device name
- Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
- Device class
- Class 3
- Medical specialty
- Unknown
- Marketing pathway
- PMA
FDA classification definition
The anaplastic lymphoma kinase (ALK) antibody is a qualitative immunohistochemical antibody intended to identify ALK protein expression in human clinical tissue specimens. The ALK antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Official FDA classification page: PKW
Classification and pathway per current FDA publications. Data from openFDA (CC0).