
Fujirebio Diagnostics,Inc.
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HE4 EIA, MODEL: 404-10 US is an FDA 510(k)-cleared medical device (K072939) 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 June 8, 2008. Regulation: 8.