FDA clears IVD assay to assess complete response in multiple myeloma

The US FDA has granted 510(k) clearance for the Hydrashift 2/4 daratumumab assay from Sebia, which is intended for use with Hydragel IF for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis. more

25 Jan 2018 16:45 Technology