- Device
- PD-L1 IHC 22C3 pharmDx
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P150013
- Supplement
- S025
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2022-11-03
- Decision code
- APPR
- Date received
- 2022-08-08
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval of the cut section storage recommendation for cervical cancer tissue will be updated, to change the recommended maximum duration of storage at 2-8ºC from 5 months to 2 months.