DENV Detect NS1 ELISA

DENV Detect NS1 ELISA is an FDA 510(k)-cleared medical device (K181473) manufactured by InBios International, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 26, 2018. Regulation: 8.