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Medical Devices / Submissions and Approvals

Quidel Receives FDA 510(k) Clearance for Lyme Assay

March 7, 2018

Quidel received FDA 510(k) clearance to market its Sofia Lyme fluorescent immunoassay to aid in diagnosis of Lyme disease.

The assay detects antibodies to Borrelia burgdorferi in serum and plasma specimens from patients suspected of B. burgdorferi infection. In the United States, Lyme disease is caused by the bacterium and is transmitted through the bite of an infected tick.

The assay works with Quidel’s Sofia and Sofia 2 systems. Sofia 2 integrates wireless connectivity and a barcode scanner in a smaller footprint than the legacy Sofia equipment. It also comes connected to Quidel’s Virena data management system, which provides aggregated, de-identified testing data in near real-time.

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