BD receives FDA 510 (Ok) clearance for quick point-of-care Covid-19-Take a look at-the Journal of Healthcare Contracting

BD receives FDA 510 (Ok) clearance for quick point-of-care Covid-19-Take a look at-the Journal of Healthcare Contracting

31 juli 2025-BD kondigde aan dat het de Amerikaanse Meals and Drug Administration (FDA) 510 (okay) -klaring heeft ontvangen voor het BD Veritor ™ -systeem voor SARS-COV-2, een digitale take a look at die is ontworpen om COVID-19-antigenen te detecteren bij symptomatische personen in ongeveer 15 minuten in artsen, urgente zorgcentra, raakklinieken en andere handelscontinieken en andere handelsopdrachten en andere Healthcare establishments.

The BD Veritor ™ system for SARS-COV-2 has been accessible since September 2020 underneath Emergency Consumer Authorization (EUA) of the FDA. The brand new 510 (Ok) Staring will ultimately substitute the present EU model of the take a look at, beginning at first of autumn 2025.

“This FDA approval is a part of our steady dedication to assist healthcare suppliers with dependable, quick diagnostic instruments,” stated Nikos Pavlidis, international president of BD Diagnostic Options. “The BD Veritor ™ system for SARS-COV-2 has proved to be a dependable COVID-19 take a look at with a streamlined workflow and clear digital outcomes, which helps clinicians to make confident and well timed choices that may assist enhance the affected person's outcomes.”

The BD Veritor ™ system for SARS-COV-2 is a chromatographic, digital lateral-immunoassay that produces goal, easy-to-read outcomes utilizing the BD Veritor ™ Plus Analyzer. The take a look at is meant to be used in Clia-Waived environments and provides outcomes from nasal cotton buds of sufferers inside six days after the beginning of the signs.

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