- Device
- PD-L1 IHC 22C3 pharmDx
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P150013
- Supplement
- S017
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2020-03-19
- Decision code
- APPR
- Date received
- 2019-06-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approved to migrate the PD-L1 IHC 22C3 pharmDx assay for NSCLC indication for use on the Dako Omnis automated staining system per approval letter.