QQT — Immunohistochemistry Assay, Antibody, Ki-67 Class III
FDA product code QQT covers "Immunohistochemistry Assay, Antibody, Ki-67", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QQT
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Unknown
- Implant
- No
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.