D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT

D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT is an FDA 510(k)-cleared medical device (K091171) 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 September 10, 2009. Regulation: 8.