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Centers for Disease Control and Prevention
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CDC DENV-1-4 REAL TIME RT-PCT ASSAY is an FDA 510(k)-cleared medical device (DEN120012) manufactured by Centers for Disease Control and Prevention. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 2012. Regulation: 8.