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Quidel assays available in EU countries

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March 2019—Quidel has received the CE mark for its Sofia Quantitative Vitamin D FIA for use with the Sofia fluorescent immunoassay analyzer for the quantitative determination of total 25-OH vitamin D from serum samples. The test is intended for use with the Sofia analyzer to aid in the assessment of vitamin D sufficiency and is the first quantitative assay on the Sofia.

The company also received the CE mark for its point-of-care Sofia 2 Lyme+ FIA to be used with the Sofia 2 fluorescent immunoassay analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi, Borrelia garinii, and Borrelia afzelii from serum and plasma specimens.

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