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Quidel Receives FDA Clearance for Its Point-of-Care Sofia® Lyme FIA
SAN DIEGO--(BUSINESS WIRE)--Oct. 23, 2017--
Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid
diagnostic testing solutions, cellular-based virology assays and
molecular diagnostic systems, announced today that it has received
510(k) clearance from the United States Food and Drug Administration
(FDA) to market its Sofia Lyme FIA for the rapid differential detection
of human IgM and IgG antibodies to Borrelia burgdorferi from
serum and plasma specimens from patients suspected of B. burgdorferi
infection. The test is intended for use with the Sofia analyzer to aid
in the diagnosis of Lyme disease.
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