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Medical Devices / Submissions and Approvals

Meso Scale Diagnostics Wins FDA Nod for IVD Assay

Feb. 1, 2018

Maryland-based immunoassay developer Meso Scale Diagnostics received FDA clearance for its conventional C-reactive protein assay for in vitro diagnostic use.

The CRP assay features the company’s proprietary MULTI-ARRAY technology and its MESO SECTOR S 700 for the detection of analytes in bodily fluids.

The assay provides an “attractive alternative” to traditional diagnostic test systems, the company said.

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