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Home » Quidel’s Lyme Fluorescent Immunoassay Cleared by FDA
Quidel’s Lyme Fluorescent Immunoassay Cleared by FDA
![ClearanceStamp_Gray.gif](https://www.fdanews.com/ext/resources/test/Device_Images6/ClearanceStamp_Gray.gif?t=1576043982&width=430)
August 31, 2018
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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