www.fdanews.com/articles/185442-meso-scale-diagnostics-wins-fda-nod-for-ivd-assay
Meso Scale Diagnostics Wins FDA Nod for IVD Assay
January 31, 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.