LEICA BIOSYSTEMS NEWCASTLE LTD DS9397 BOND-PRIME

For in vitro diagnostic use.ChromoPlex 1 Dual Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker and polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the visualization of tissue-bound mouse IgG and rabbit primary antibodies. It is intended for target visualization by immunohistochemistry (IHC) in sections of formalin fixed, paraffin-embedded tissue using the automated BOND-PRIME system.The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.ChromoPlex 1 Dual Detection for BOND-PRIME is intended to be used with other devices for visualization of staining and as such, qualitative or semi-quantitative diagnostic function including specific disease indication and intended use population is described within the associated device labelling as required for that device.