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Diagnostic Hybrids, Inc.
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D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT is an FDA 510(k)-cleared medical device (K081746) manufactured by Diagnostic Hybrids, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 22, 2008. Regulation: 8.