Sofia® 2 Lyme Fluorescent Immunoassay: Quidel Receives FDA Clearance, CLIA Waiver

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced this week that it has received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver from the United States Food and Drug Administration (FDA) to market its Sofia 2 Lyme FIA to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid differential ["]

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