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PMA P150013S026

Device
PD-L1 IHC 22C3 pharmDx
Applicant
Agilent Technologies, Inc.
PMA number
P150013
Supplement
S026
Product code
PLS
Decision date
2023-07-05
Classification
Pathology
Generic name
Immunohistochemistry assay, antibody, programmed death-ligand 1
Approval order statement
Approval for updates to Instructions for Use and manufacturing quality control technical procedure intended to mitigate nonspecific nuclear staining in formalin-fixed, paraffin-embedded (FFPE) tumor specimens stained with the Negative Control Reagent (NCR) from PD-L1 IHC 22C3 pharmDx.

Current openFDA PMA Record#

Device
PD-L1 IHC 22C3 pharmDx
Applicant
Agilent Technologies, Inc.
PMA number
P150013
Supplement
S026
Product code
PLS
Generic name
Immunohistochemistry assay, antibody, programmed death-ligand 1
Decision date
2023-07-05
Decision code
APPR
Date received
2023-06-12
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for updates to Instructions for Use and manufacturing quality control technical procedure intended to mitigate nonspecific nuclear staining in formalin-fixed, paraffin-embedded (FFPE) tumor specimens stained with the Negative Control Reagent (NCR) from PD-L1 IHC 22C3 pharmDx.