Ventana VENTANA PD-L1 (SP142) Assay - HSA Registration DE0510229
Access comprehensive regulatory information for Ventana VENTANA PD-L1 (SP142) Assay in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0510229 and owned by Ventana Medical Systems, Inc.. The device was registered on January 10, 2025.
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VENTANA PD-L1 (SP142) Assay is intended for laboratory use in the qualitative immunohistochemical assessment of the programmed death-ligand 1 (PD-L1) protein in tumor cells and tumor-infiltrating immune cells in formalin-fixed, paraffin-embedded (FFPE) tissues indicated below stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a BenchMark IHC/ISH instrument. Determination of PD-L1 status is indication-specific and evaluation is based on either the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity or the percentage of PD-L1 expressing tumor cells (% TC) of any intensity. VENTANA PD-L1 (SP142) Assay is indicated as an aid for identifying patients for treatment with the therapies listed below for the respective indications and cutoffs in accordance with the approved therapeutic product labeling. Triple-Negative Breast Carcinoma - TECENTRIQ -≥ 1% IC cutoff