Product code QQT

Device name

Immunohistochemistry Assay, Antibody, Ki-67

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 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.

Source

FDA openFDA device classification dataset