
Elias U.S.A., Inc.
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ELIAS CARDIOLIPIN ANTIBODIES is an FDA 510(k)-cleared medical device (K940403) manufactured by Elias U.S.A., 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 September 19, 1994. Regulation: 8.