
Centers for Disease Control and Prevention
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CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL is an FDA 510(k)-cleared medical device (K101564) 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 June 21, 2010. Regulation: 8.