For in vitro diagnostic use. Cytoplasm Others ALK D5F3 CDx Assay VENTANA IVD Appendix VENTANA® ALK (D5F3) CDx Assay RTD001188 US-FDA Rabbit D5F3 06687199001 VENTANA ALK (D5F3) CDx Assay VENTANA ALK (D5F3) CDx Assay 04015630970094 Reagents, kits 790-4796 50 tests Not Available true VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib), ZYKADIA® (ceritinib), ALECENSA® (alectinib) or LORBRENA® (lorlatinib). This product 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 ALK (D5F3) CDx Assay is a rabbit monoclonal primary antibody that binds to ALK in paraffin-embedded tissue sections. The specific antibody can be visualized using OptiView DAB IHC Detection Kit (Cat. No. 760-700 / 06396500001) followed by the OptiView Amplification Kit (Cat. No. 760-099 / 06396518001 (50 test) or 860-099 / 06718663001 (250 test)). Refer to the appropriate OptiView DAB IHC Detection Kit and OptiView Amplification Kit package inserts (method sheets) for further information. en