ICON STREP B IMMUNOENZYMETRIC ASSAY

ICON STREP B IMMUNOENZYMETRIC ASSAY is an FDA 510(k)-cleared medical device (K902991) 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 October 2, 1990. Regulation: 8.