
Meridian Bioscience, Inc.
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STREPTOCOCCUS APP. SEROLOGICAL REAGENTS is an FDA 510(k)-cleared medical device (K122019) manufactured by Meridian Bioscience, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 12, 2012. Regulation: 8.