Device Dossier

PD-L1 IHC 22C3 pharmDx - Immunohistology cell marker IVDs

Device Dossier for PD-L1 IHC 22C3 pharmDx - Immunohistology cell marker IVDs (CT1056 - Immunohistology cell marker IVDs, Class 3, sponsor Agilent…

Intended purpose

For in vitro diagnostic use. PD-L1 IHC 22C3 pharmDx is a qualitative IHC assay for use in the detection of PD-L1 protein in FFPE cancer tissues on Autostainer Link 48. It is indicated as an aid in identifying NSCLC, HNSCC, TNBC, Cervical Cancer, and Gastric or GEJ patients for treatment with KEYTRUDA® and NSCLC patients for treatment with LIBTAYO® according to the approved indication specific PD-L1 expression levels. The trademarks above are owned by their respective owners

Functional description

PD-L1 IHC 22C3 pharmDx uses mouse anti-human PD-L1, clone 22C3 on FFPE tissue specimens in an automated IHC staining procedure to detect PD-L1.

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