Ventana VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx - HSA Registration DE0509909
Access comprehensive regulatory information for Ventana VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx 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 DE0509909 and owned by Ventana Medical Systems, Inc.. The device was registered on October 14, 2024.
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VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx is intended for the semi-quantitative detection of HER2 antigen by immuno-histochemistry (IHC) in sections of formalin-fixed, paraffin-embedded breast and gastric tissue stained on a BenchMark IHC/ISH instrument. This IHC device is indicated for identifying breast cancer patients who are eligible for treatment with trastuzumab (IHC 3+ or IHC 2+/ISH amplified), pertuzumab (IHC 3+ or IHC 2+/ISH amplified), trastuzumab emtansine (IHC 3+ or IHC 2+/ISH amplified), or fam-trastuzumab deruxtecan-nxki (IHC 1+ or IHC 2+/ISH non-amplified). Additionally, this IHC device is indicated as an aid in the assessment of gastric cancer patients for whom trastuzumab treatment is being considered (IHC 3+ or IHC 2+/ISH amplified). This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This antibody is intended for in vitro diagnostic (IVD) use.