VIDAS ESTRADIOL (E2) ASSAY

VIDAS ESTRADIOL (E2) ASSAY is an FDA 510(k)-cleared medical device (K925498) manufactured by Biomerieux Vitek, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 11, 1993. Regulation: 8.