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Lumos Receives US FDA Clearance for FebriDx australiannews.net - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from australiannews.net Daily Mail and Mail on Sunday newspapers.
Lumos Receives US FDA Clearance for FebriDx asiabulletin.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from asiabulletin.com Daily Mail and Mail on Sunday newspapers.
MELBOURNE, Australia, July 3, 2023 /PRNewswire/ Lumos Diagnostics(ASX: LDX), ("Lumos" or the "Company") a leader in rapid, point-of-care (POC) diagnostic technologies, is pleased to announce that it has received clearance from the US Food and Drug Administration (FDA) to market its FebriDx rapid, point-of-care test in the United States. The clearance allows FebriDx to be marketed in the US for use by healthcare professionals as an aid in the diagnosis of bacterial acute respiratory infection and differentiation from non-bacterial etiology in patients presenting in urgent care or emergency care settings. FebriDx is intended to be used in conjunction with clinical signs and symptoms, including other clinical and laboratory findings, to evaluate patients for acute respiratory infection. Following a presubmission meeting in January 2023, Lumos submitted a new 510(k) application for FebriDx to the FDA earlier this year. The FDA has completed its review of this new appl ....
MELBOURNE, Australia, July 3, 2023 /PRNewswire/ Lumos Diagnostics(ASX: LDX), ("Lumos" or the "Company") a leader in rapid, point-of-care (POC) diagnostic technologies, is pleased to announce that it has received clearance from the US Food and Drug Administration (FDA) to market its FebriDx rapid, point-of-care test in the United States. The clearance allows FebriDx to be marketed in the US for use by healthcare professionals as an aid in the diagnosis of bacterial acute respiratory infection and differentiation from non-bacterial etiology in patients presenting in urgent care or emergency care settings. FebriDx is intended to be used in conjunction with clinical signs and symptoms, including other clinical and laboratory findings, to evaluate patients for acute respiratory infection. Following a presubmission meeting in January 2023, Lumos submitted a new 510(k) application for FebriDx to the FDA earlier this year. The FDA has completed its review of this new appl ....