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www.fdanews.com/articles/164022-quidel-receives-fda-clearance-for-lyra-molecular-pcr-assay-for-detection-of-infections-from-pyogenic-streptococcus-group-a-and-c-or-g

Quidel Receives FDA Clearance for Lyra Molecular PCR Assay for Detection of Infections From Pyogenic Streptococcus Group A and C or G

April 23, 2014
Quidel has received clearance, via the De Novo Request process, from the FDA to market its Lyra Direct Strep Assay, a multiplex real-time PCR assay. This new molecular test detects and differentiates between pyogenic Group A and pyogenic C or G Streptococcal throat infections.
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