Quidel receives 510(k) clearance for Influenza A+B assay

Quidel received FDA clearance in December 2011 to run its Quidel Molecular Influenza A+B and hMPV assays on Life Technologies’ Applied Biosystems 7500 Fast DX thermocycler.

The product was launched in Europe for use with both thermocyclers shortly after receiving the CE Mark in August 2011.

Quidel president and chief executive officer Douglas Bryant said the company received FDA clearance to run its molecular flu test on Cepheid’s SmartCycler.

"This claim will provide health care workers in established molecular laboratories with a versatile, high-performance diagnostic product without making additional investments in their molecular infrastructure," Bryant added.