TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT

TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT is an FDA 510(k)-cleared medical device (K860778) manufactured by Hybritech, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 3, 1986. Regulation: 8.