D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT

D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT is an FDA 510(k)-cleared medical device (K093233) manufactured by Diagnostic Hybrids, 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 December 3, 2009. Regulation: 8.