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Tag Archives: Janssen Biotech—

FDA clears Sebia Hydrashift 2/4 daratumumab assay

Feb. 26, 2018—Sebia announced it has received FDA 510(k) clearance for its Hydrashift 2/4 daratumumab assay, intended to be used with Hydragel IF, for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis. This in vitro diagnostic reagent mitigates the daratumumab-mediated interference seen in immunofixation results for patients with multiple myeloma treated with Darzalex (daratumumab), a fully ...

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