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NEW YORK (GenomeWeb) – The US Food and Drug Administration has granted 510(k) clearance for a Lyme disease test on Quidel's Sofia platform, the company announced today.

The Sofia Lyme FIA is the first assay to provide differentiated results for both IgM and IgG antibodies against Borrelia burgdorferi, the microorganism transmitted by tick bites, on a single test, Quidel noted in a statement.

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