Product code PKW

Device name

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

Medical specialty

Unknown

Device class

3

Review panel

PA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset