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Beckman Coulter, Inc.
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ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY is an FDA 510(k)-cleared medical device (K031606) manufactured by Beckman Coulter, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 19, 2003. Regulation: 8.