SER

Immunohistochemistry Assay, Antibody, Met

Product code
SER
Device name
Immunohistochemistry Assay, Antibody, Met
Device class
Class 3
21 CFR
21 CFR 864.1860
Medical specialty
Hematology
Marketing pathway
PMA

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: SER
Classification and pathway per current FDA publications. Data from openFDA (CC0).