Home » Quidel’s Lyme Fluorescent Immunoassay Cleared by FDA
Quidel’s Lyme Fluorescent Immunoassay Cleared by FDA
Quidel received FDA clearance for its Sofia 2 lyme fluorescent immunoassay, used in conjunction with its fluorescent immunoassay analyzer to detect human IgM and IgG antibodies.
The assay is used to rapidly diagnose Borrelia burgdorferi — lyme disease — from finger-stick whole blood specimens.
The device integrates wireless connectivity with an updated graphical user interface and optic system.
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