PMA P150013
- Device
- PD-L1 IHC 22C3 pharmDx
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P150013
- Supplement
- S025
- Product code
- PLS
- Decision date
- 2026-09-11
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Approval order statement
- approval of manufacturing process and equipment changes for filling and capping
Current openFDA PMA Record#
- Device
- PD-L1 IHC 22C3 pharmDx
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P150013
- Supplement
- S035
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2026-09-11
- Decision code
- OK30
- Date received
- 2026-08-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of manufacturing process and equipment changes for filling and capping