This antibody is intended for in vitro diagnostic (IVD) use. The Cell Marque IgG4 (MRQ-44) 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 IgG4-related sclerosing diseases within the context of an antibody panel, the patient’s clinical history, and other diagnostic tests evaluated by a qualified pathologist.

Instructions For Use (IFU)

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.