LumiraDx said on Wednesday that it has received CE marking for a molecular SARS-CoV-2 test and an assay that tests for both SARS-CoV-2 and influenza virus.
The US Food and Drug Administration last week granted DxLab Emergency Use Authorization for its molecular DxLab COVID-19 test.
Pfizer Inc. announced today that it will further strengthen its commitment to United States manufacturing with a $120 million investment at its Kalamazoo, Michigan, facility, enabling U.S.-based production in support of its COVID-19 oral treatment.
The US Food and Drug Administration this week granted Emergency Use Authorization for LG Chem's AdvanSure SARS-CoV-2 IgG(RBD) ELISA COVID-19 antibody test.
The Food and Drug Administration’s Center for Devices and Radiological Health plans to start accepting pre-submission requests for in vitro diagnostics starting on June 1, including for tests not related to COVID-19.
This is the 68th edition of our annual ranking of America’s largest companies, and it was a blowout year for the companies featured—despite rising inflation, the ongoing supply chain crisis, and the second year of the COVID-19 pandemic.
On May 26, 2022, the team of Xiamen University, Hong Kong University, Wantai Biopharm and China National Institute for Food and Drug Control published online research results.
Becton Dickinson announced on Thursday that it has obtained the CE-IVD mark for a combined influenza, SARS-CoV-2 assay. The multiplexed RT-PCR test runs on the firm's high-throughput BD Cor system.
On May 19, the COVID-19 Antigen Rapid Test (colloidal gold method) independently developed by Guangzhou Weimi Bio-Tech Co., Ltd (“Weimi Bio-Tech”) successfully obtained the EU CE certificate.
Google confirmed the hire and said Bakul Patel will report to Linda Peters, vice president of quality, regulatory and safety at Google Health.
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