Following approval, the company will market its influenza A+B assay in the US.
Quidel’s product portfolio includes PCR reagent kits for use by molecular diagnostic laboratories with its existing Applied Biosystems 7500 Fast DX thermocycler.
Quidel president and CEO Douglas Bryant said the Quidel molecular influenza A+B assay provides users a reliable, easy-to-use option for the diagnosis of influenza virus infections.
"We are very pleased with the timely FDA clearance of this molecular product," Bryant added.
The assay was launched in Europe in August 2011.