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Home › Business, Policy & Funding › Regulatory News & FDA Approvals › FDA Clears Quidel Lyme Disease Immunoassay for Sofia 2

FDA Clears Quidel Lyme Disease Immunoassay for Sofia 2

Mar 05, 2018
|
staff reporter

NEW YORK (360Dx) – Quidel said after the close of the market on Monday that the US Food and Drug Administration has cleared the company's Sofia Lyme FIA test to run on the Sofia 2 Fluorescent Immunoassay Analyzer.

As a result , Quidel can now market the assay on the next-generation version of the Sofia instrument in the US.

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