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Remel, Inc.
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XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 is an FDA 510(k)-cleared medical device (K031942) manufactured by Remel, 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 November 17, 2003. Regulation: 8.