VIDAS ESTRADIOL II (E2II) ASSAY

VIDAS ESTRADIOL II (E2II) ASSAY is an FDA 510(k)-cleared medical device (K955647) 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 5, 1996. Regulation: 8.