The 510(k) clearance from the FDA facilitates the company to market its Quidel molecular hMPV assay in the US.
Quidel president and CEO Douglas Bryant said they are pleased about the approval of its first molecular offering in the US, and are excited with their continued execution of the R&D pipeline.
The Quidel molecular hMPV assay received CE Mark approval in September 2011.
The Quidel molecular product line offers reagents that provide for simple transport and storage of the kit, convenient workflow, a short time to result, and favorably affect diagnostic test outcome.
