For in vitro diagnostic use. Membrane Others VENTANA CLDN18 43-14A RxDx Assay IVD Gastric intestinal metaplasia (positive) VENTANA® CLDN18 (43-14A) RxDx Assay PID00000600 US-FDA Mouse 43-14A 08 287 066 001 8 287 066 001 08287066001 8287066001 08287066001 VENTANA CLDN18 (43-14A) RxDx Assay VENTANA CLDN18 (43-14A) RxDx Assay 07613336149201 Reagents, kits 740-7037 50 tests Not Available VENTANA CLDN18 (43-14A) RxDx Assay is a qualitative immunohisto-chemical assay using mouse monoclonal anti-claudin 18, clone 43-14A, intended for laboratory use in the assessment of claudin 18 (CLDN18) protein in formalin-fixed, paraffin-embedded (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 ULTRA 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 for the therapeutic product is ≥75% viable 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 in vitro diagnostic (IVD) use. en VENTANA CLDN18 (43-14A) RxDx Assay is a mouse monoclonal primary antibody which binds to CLDN18 protein in FFPE tissue sections. The specific antibody can be located by using OptiView DAB IHC Detection Kit (Cat. No. 760-700 / 06396500001). Refer to the OptiView DAB IHC Detection Kit method sheet (package insert) for further information. en

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VENTANA^® CLDN18 (43-14A) RxDx Assay

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