This antibody is intended for in vitro diagnostic (IVD) use. Ventana Medical Systems, Inc. (Ventana) CONFIRM anti-p53 (DO-7) primary antibody is a mouse monoclonal antibody (IgG1, kappa) directed against human p53. The antibody is intended for laboratory use to qualitatively identify by light microscopy wild type and mutant p53 in sections of formalin fixed, paraffin embedded tissue 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. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.