QQT

Immunohistochemistry Assay, Antibody, Ki-67

Product code: QQT
Device name: Immunohistochemistry Assay, Antibody, Ki-67
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification definition

The Ki-67 antibody is a qualitative immunohistochemical antibody intended to identify Ki-67 protein expression in human clinical tissue specimens. The KI-67 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: QQT

Classification and pathway per current FDA publications. Data from openFDA (CC0).