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Immco Diagnostics, Inc.
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IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA is an FDA 510(k)-cleared medical device (K030701) manufactured by Immco 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 September 8, 2003. Regulation: 8.