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Quidel Receives FDA Clearance, CLIA Waiver for Its Point-of-Care Sofia® 2 Lyme Fluorescent Immunoassay for Use with Sofia® 2 Instrument from Finger-Stick Whole Blood Specimens

SAN DIEGO--(BUSINESS WIRE)--Aug. 30, 2018--
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 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 detection of human IgM
and IgG antibodies to Borrelia burgdorferi from finger-stick
whole blood specimens from patients suspected of B. burgdorferi
infection. The test is intended for use with the Sofia 2 analyzer to aid
in the diagnosis of Lyme disease.

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