Chester County News and Community Website
The U.S. Food and Drug Administration recently published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The tables show the Limit of Detection (LoD) of more than 55 …
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The U.S. Food and Drug Administration this week issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the …
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The U.S. Food and Drug Administration recently issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method …
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The U.S. Food and Drug Administration reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use: testing for people who do not have …
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EXTON, PA — Megna Health, a medical technology company focused on the development and manufacturing of diagnostic and healthcare products, announced recently that the Company has received Emergency Use Authorization …
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WASHINGTON, D.C. — The U.S. Department of Health and Human Services (HHS) this week announced a large-scale procurement of U.S. Food and Drug Administration (FDA) -authorized rapid point-of-care diagnostic test …
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WASHINGTON, D.C. — The U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for a COVID-19 antigen diagnostic test, the BD (Becton Dickinson) Veritor System for Rapid Detection …
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WASHINGTON, D.C. — The U.S. Food and Drug Administration has taken an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health …
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WASHINGTON, D.C. — The U.S. Food and Drug Administration revoked the emergency use authorization (EUA) of the Chembio Diagnostic System, Inc. (Chembio) DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, …
Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration is warning health care providers about a newly discovered potential drug interaction related to the investigational antiviral drug remdesivir, which has …
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