
Meso Scale Diagnostics, LLC
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MSD CRP Assay Kit and MESO SECTOR S 700 Instrument is an FDA 510(k)-cleared medical device (K171498) manufactured by Meso Scale Diagnostics, LLC. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 11, 2018. Regulation: 8.