Quidel, a developer of diagnostic solutions to the health care system, has obtained the US Food and Drug Administration (FDA) 510(k) clearance for its molecular diagnostic test- Quidel molecular influenza A+B assay, used to identify influenza A and B.
The clearance allows the company to market its influenza A+B assay in the US, which was launched in Europe in August 2011.
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 company’s product line includes PCR reagent kits for use by molecular diagnostic laboratories with its existing Applied Biosystems 7500 Fast DX thermocycler.