US-based Meridian Bioscience has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its TRU FLU assay for an analytical sensitivity claim for the avian Influenza H7N9 strain, A/Anhui/1/2013.
According to Meridian Bioscience, its TRU FLU rapid immunoassay detects influenza A and influenza B viruses in 15 minutes in human respiratory specimens.
Meridian Bioscience CEO John A Kraeutler noted the company is committed to providing accurate and rapid diagnostic solutions as novel flu strains emerge globally.
"During the 2009 H1N1 pandemic, Meridian received special 510(k) FDA clearance to add H1N1 analytical sensitivity claim for TRU FLU. Once again, Meridian knew that it was critically important to be prepared for a potential pandemic with the novel avian H7N9 strain to provide the best patient care," Kraeutler added.
The company’s TRU FLU and TRU RSV products provide closed systems that limit the exposure of laboratory personnel to infectious agents in test samples during incubation and disposal.