
Gen-Probe Prodesse, Inc.
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PRO HMPV+ ASSAY is an FDA 510(k)-cleared medical device (K123838) 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 January 15, 2013. Regulation: 8.