
Diagnostic Hybrids, Inc.
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MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT is an FDA 510(k)-cleared medical device (K092300) 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 August 27, 2009. Regulation: 8.