Ventana VENTANA CLDN18 (43-14A) RxDx Assay - HSA Registration DE0510669
Access comprehensive regulatory information for Ventana VENTANA CLDN18 (43-14A) RxDx 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 DE0510669 and owned by Ventana Medical Systems, Inc.. The device was registered on May 02, 2025.
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VENTANA CLDN18 (43-14A) RxDx Assay is a qualitative IHC assay using mouse monoclonal anti-claudin 18, clone 43-14A, intended for laboratory use in the assessment of claudin 18 (CLDN18) protein in FFPE gastric adenocarcinoma including gastroesophageal junction (GEJ) tissue specimens by light microscopy. This assay is used with OptiView DAB IHC Detection Kit for staining on a BenchMark IHC/ISH instrument. The assay is indicated as an aid in identifying patients with gastric or GEJ adenocarcinoma who may be eligible for treatment with VYLOY™ (zolbetuximab) in accordance with the approved therapeutic product labeling. The clinical cutoff is ≥75% tumor cells (%TC) demonstrating moderate to strong membrane CLDN18 staining above background. Test results of the VENTANA CLDN18 (43-14A) RxDx Assay should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This product is intended for IVD use.