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Gen-Probe Prodesse, Inc.
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PROFLU+ ASSAY is an FDA 510(k)-cleared medical device (K110968) 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 June 26, 2011. Regulation: 8.