NEW YORK (GenomeWeb News) – Quidel said today that it has received 510(k) clearance from the US Food and Drug Administration for its Quidel Molecular Influenza A+B assay for use with the Cepheid SmartCycler PCR system.
Quidel received FDA clearance for the same assay in December for use on Life Technologies' ABI 7500 Fast Dx thermal cycler.
Quidel launched the Influenza A+B assay in Europe for use with both the SmartCycler and 7500 Fast in August after receiving the CE-IVD Mark.
The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories with their existing thermocyclers. The 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," the San Diego-based company said in a statement.