PMA P150013S029

Device: PD-L1 IHC 22C3 pharmDx
Applicant: Agilent Technologies, Inc.
PMA number: P150013
Supplement: S029
Product code: PLS
Decision date: 2025-02-28
Classification: Pathology
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Approval order statement: Approval for additional quality control tests to raw materials and intermediates that to enhance safety of the finished devices without impacting effectiveness.

Current openFDA PMA Record#

Device: PD-L1 IHC 22C3 pharmDx
Applicant: Agilent Technologies, Inc.
PMA number: P150013
Supplement: S029
Product code: PLS
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Decision date: 2025-02-28
Decision code: APPR
Date received: 2025-01-31
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for additional quality control tests to raw materials and intermediates that to enhance safety of the finished devices without impacting effectiveness.