
Prodesse, Inc.
Free shipping on orders over $99 · 30-day returns
MODIFICATION TO PROFLU+ ASSAY is an FDA 510(k)-cleared medical device (K092500) manufactured by 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 19, 2009. Regulation: 8.