
Fujirebio Diagnostics,Inc.
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ARCHITECT CA 125 II ASSAY is an FDA 510(k)-cleared medical device (K042731) manufactured by Fujirebio Diagnostics,Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 18, 2004. Regulation: 8.