Stat-Technologies (Golden Valley, MN) announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for the COVID-19 IgG/IgN rapid test kits it carries. The tests offered by Stat-technologies are manufactured by Healgen Scientific. According to the company, the FDA authorization and Preferred-Provider status allows … [Read more...]
Quidel receives amended Emergency Authorization for rapid antigen COVID-19 diagnostic assay using Sofia 1 instrument
Quidel Corporation (San Diego, CA) announced it has received an amended Emergency Use Authorization (EUA) from the FDA, allowing Quidel to run its Sofia SARS Antigen FIA, a rapid point-of-care test for COVID-19, on the Sofia Fluorescent Immunoassay Analyzer (Sofia 1), Quidel’s first-generation automated immunoassay instrument. Quidel previously received EUA to run the Sofia … [Read more...]
Sekisui Diagnostics announces FDA clearance, CLIA Waiver of OSOM Ultra Plus Flu A&B Test
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...]