PRODESSE PROFLU+ ASSAY

PRODESSE PROFLU+ ASSAY is an FDA 510(k)-cleared medical device (K132129) manufactured by Gen-Probe Prodesse, 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 8, 2013. Regulation: 8.