Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

PKW · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: PKW
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: PA
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown