"While this is the first marketing authorization for a diagnostic test using a traditional premarket review process, we do not expect this to be the last and look forward to working with developers of medical products to move their products through our traditional review pathways." Related:įollowing the test's FDA emergency approval in May 2020, BioFire said the panel allows health care providers to quickly identify patients with common respiratory pathogens as well as those with COVID-19 using one simple test.
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"We ensured there were tests made available quickly under Emergency Use Authorization and we continue to work with diagnostic manufacturers to take the next step of ensuring products are FDA reviewed for safety and effectiveness and authorized for marketing under our traditional premarket authorities. "Today's action is a great demonstration of the FDA's work to protect the public health in emergency response situations and beyond," Woodcock said in a statement.
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Janet Woodcock said the BioFire authorization will help pave the way for additional full authorizations of critical COVID-19 diagnostic tests. On Wednesday, the FDA said it had granted marketing authorization of the BioFire Respiratory Panel 2.1, a diagnostic test for the detection and identification of multiple respiratory viral and bacterial infections obtained from individuals suspected of COVID-19 and other respiratory tract ailments.įDA Acting Commissioner Dr. Food and Drug Administration approval, the agency announced this week. SALT LAKE CITY - A COVID-19 test developed in Utah and granted emergency use authorization in the early days of the pandemic last year has become the first such test to earn full U.S. Reading or replaying the story in its archived form does not constitute a republication of the story.
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