February 2020—Curetis announced it has received FDA 510(k) clearance to market its Unyvero LRT Lower Respiratory Tract application cartridge for use with bronchoalveolar lavage samples to diagnose lower respiratory tract infections such as pneumonia.
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FDA clears Curetis Unyvero LRT for BAL specimens
Jan. 7, 2020—Curetis announced it has received FDA 510(k) clearance to market its Unyvero LRT Lower Respiratory Tract application cartridge for use with bronchoalveolar lavage samples to diagnose lower respiratory tract infections such as pneumonia.
Read More »Unyvero System gets de novo clearance
June 2018—Curetis has been granted de novo clearance by the FDA to market the Unyvero System and Lower Respiratory Tract Infection Application Cartridge in the U.S.
Read More »Principal investigator named for Unyvero LRT trial, 8/14
August 2014—Curetis announced that Robin Patel, MD, professor of medicine and microbiology at Mayo Clinic in Rochester, Minn., has been named lead principal investigator of the company’s Unyvero LRT Application FDA trial.
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