September 4, 2020 - Roche (Basel, Switzerland) announced that the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This test is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B in … [Read more...]
Quidel provides business update, isn’t concerned by Abbott’s new SARS antigen test
August 28, 2020 - Quidel Corporation (San Diego, CA) yesterday announced business updates and reaffirmed that it is “an industry leader in the introduction of FDA-authorized rapid tests for a wide range of diseases and medical conditions, [and] remains in the forefront of the battle against the COVID-19 pandemic.” Competition Was Expected “Abbott’s entry into the SARS … [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...]