This antibody is intended for in vitro diagnostic use.
Ventana Medical Systems' (Ventana) CONFIRM anti-Melanosome (HMB45) is a mouse monoclonal antibody (IgG1, kappa) directed against an oncofetal antigen present within immature melanosomes in the cytoplasm of activated and neoplastic melanocytes. CONFIRM anti-Melanosome (HMB45) is intended for laboratory use to qualitatively detect, via light microscopy, cells containing immature melanosomes in sections of formalin-fixed, paraffin-embedded tissue following staining on a Ventana automated slide stainer. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests.