ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS

ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS is an FDA 510(k)-cleared medical device (K854129) manufactured by Orion Diagnostica, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 20, 1986. Regulation: 8.