ROMA (HE4 EIA + ARCHITECT CA 125 II)

ROMA (HE4 EIA + ARCHITECT CA 125 II) is an FDA 510(k)-cleared medical device (K103358) manufactured by Fujirebio Diagnostics,Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 31, 2011. Regulation: 8.