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Quidel Corp.
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QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199 is an FDA 510(k)-cleared medical device (K061008) manufactured by Quidel Corp.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 7, 2006. Regulation: 8.