QQT · Immunohistochemistry Assay, Antibody, Ki-67
· Class 3
Overview
| Product Code | QQT |
|---|---|
| Device Name | Immunohistochemistry Assay, Antibody, Ki-67 |
| Device Class | Class 3 |
| Review Panel |
Identification
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P210026 | Ki-67 IHC pharmDx | Agilent Technologies, Inc. | Oct 12, 2021 | APPR |
Top Applicants
- Agilent Technologies, Inc. — 1 clearance
