- Device
- PD-L1 IHC 22C3 pharmDx
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P150013
- Supplement
- S023
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2021-11-23
- Decision code
- APPR
- Date received
- 2021-11-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approved the removal of the urothelial carcinoma (UC) indication from the device intended use statement and labeling.