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PMA P150013S021

Device
PD-L1 IHC 22C3 pharmDx
Applicant
Agilent Technologies, Inc.
PMA number
P150013
Supplement
S021
Product code
PLS
Decision date
2021-02-22
Generic name
Immunohistochemistry assay, antibody, programmed death-ligand 1
Approval order statement
Approval for the PD-L1 IHC 22C3 pharmDX as a companion diagnostic device to detect PD-L1 protein (Tumor Proportion Score ?50%) in patients with non-small cell lung cancer (NSCLC) for treatment with LIBTAYO.

Current openFDA PMA Record#

Device
PD-L1 IHC 22C3 pharmDx
Applicant
Agilent Technologies, Inc.
PMA number
P150013
Supplement
S021
Product code
PLS
Generic name
Immunohistochemistry assay, antibody, programmed death-ligand 1
Decision date
2021-02-22
Decision code
APPR
Date received
2020-08-31
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for the PD-L1 IHC 22C3 pharmDX as a companion diagnostic device to detect PD-L1 protein (Tumor Proportion Score ?50%) in patients with non-small cell lung cancer (NSCLC) for treatment with LIBTAYO.