DevicePMAs@therightstef:P920031_S000 / 30-42
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Approval for the emit(r) 2000 cyclosporine specific assay. The device is indicated for in vitro diagnostic use on the roche diagnostics systems cobas mira, cobas mira s, and cobas mira plus chemistry systems for the quantitative analysis of cyclosporine (csa) in human whole blood as an aid in the management of cyclosporine therapy in kidney, heart, and liver transplant patients.
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