Sekisui Diagnostics announced it received FDA clearance and CLIA Waiver of the OSOM Ultra Plus Flu A&B Test intended for the qualitative detection of influenza type A and type B nucleoprotein antigens directly from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. According tot he company, the test utilizes … [Read more...]
Sysmex receives approval for safer, faster way to conduct PCR tests for novel coronavirus
Sysmex Corporation (Kobe, Japan) announced it has obtained the first marketing approval in Japan for an in vitro diagnostic medical device, a testing kit for the novel coronavirus (2019-nCoV Fluorescence Detection Real-Time RT-PCR Kit). The company subsequently filed a change request, which was approved June 2, additionally including saliva as a sample type. The company says … [Read more...]