This antibody is intended for in vitro diagnostic (IVD) use. The Cell Marque Mammaglobin (31A5) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods. Use of this antibody is indicated, subsequent to clinical differential diagnosis, as an aid in the identification of substantial proportion of primary and metastatic breast carcinomas within the context of an antibody panel, the patient’s clinical history, and other diagnostic tests evaluated by a qualified pathologist.
Leica Biosystems has not validated the performance characteristics of the Cell Marque products on the BOND and BOND-MAX analyzers. For performance data, MSDS sheets and technical trouble-shooting please contact Cell Marque directly.