Quidel Corp, San Diego, has received 510(k) clearance from the FDA for its Quidel Molecular Influenza A+B Assay for the detection of influenza A and B for use with Cepheid’s SmartCycler PCR system.
This product is one of several assays from Quidel’s expanding molecular diagnostics programs.
The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic labs with their existing thermocyclers. These kits include unique features that provide for simple transport and storage, ease of use, an attractive workflow, a short time to result and other benefits that favorably affect diagnostic test outcome.
Quidel received FDA clearance in December to run its Quidel Molecular Influenza A+B and hMPV assays on Life Technologies’ Applied Biosystems(R) 7500 Fast DX thermocycler.
"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." said Douglas Bryant, president and CEO, Quidel Corp.
The product was launched in Europe for use with both thermocyclers shortly after receiving the CE Mark in August 2011.