Programmed death-ligand 1 (PD-L1) IVD, antibody

Programmed death-ligand 1 (PD-L1) IVD, antibody tests use immunoglobulins that specifically bind to the PD-L1 protein, also called CD274, in patient samples such as tissue sections or fluid specimens. These assays help clinicians assess PD-L1 expression levels, which can guide treatment decisions, especially in oncology where PD-L1 status influences the use of immune checkpoint inhibitors.

Devices in this category are in vitro diagnostic reagents designed for qualitative or quantitative detection of PD-L1 and are typically supplied as antibodies or antibody kits for use with laboratory platforms. Their regulatory oversight follows the rules for IVD reagents, requiring compliance with applicable performance, labeling, and quality system requirements in each jurisdiction.