Product code SER

Device name

Immunohistochemistry Assay, Antibody, Met

Medical specialty

Hematology

Device class

3

Regulation number

864.1860

Review panel

PA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

The MET antibody is a qualitative immunohistochemical antibody intended to identify MET protein expression in human clinical tissue specimens. The MET antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.

Source

FDA openFDA device classification dataset