PKW — Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase Class III
FDA product code PKW covers "Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PKW
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Unknown
- Implant
- No
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.