Quidel has received FDA 510(k) clearance for its Molecular RSV and hMPV assay for the detection of respiratory syncytial virus and human metapneumovirus. The assay distinguishes between RSV and hMPV.
The RSV and hMPV assay can be batched alongside other Quidel Molecular assays, such as the influenza A and B PCR assay, in the same multiwell panel for customized multiplexing capability.
“We are pleased to have received FDA clearance for another molecular diagnostic product,” Douglas Bryant, Quidel president and CEO, said in a statement. “We intend to broaden our menu of molecular assays over the next several quarters and, in doing so, will provide our customers with a number of easy-to-use infectious disease tests that can be run on their existing thermocyclers.”
The product launched in Europe shortly after receiving the CE Mark in March 2012.
Quidel, 858-552-1100