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OpGen (OPGN) Submits De Novo request to the FDA for Unyvero Urinary Tract Infection Panel

OpGen (OPGN) Submits De Novo request to the FDA for Unyvero Urinary Tract Infection Panel
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United States , Johannes Bacher , Opgen Inc , Drug Administration , Tract Infection , Chief Operating Officer ,

OpGen Submits De Novo request to the U.S. FDA for Unyvero Urinary Tract Infection Panel

18.04.2023 - Based on large multi-center study with over 1,800 patient samplesPrimary endpoint for Unyvero UTI for urinary tract infection was successfully met and shows overall weighted average sensitivity of 96.8% and overall weighted average specificity of . Seite 1 ....

United States , Johannes Bacher , Opgen Inc , Drug Administration , Tract Infection , Chief Operating Officer ,

OpGen (OPGN) Announces Positive Top Line Data from Clinical Trial for Unyvero Urinary Tract Infection Panel

OpGen (OPGN) Announces Positive Top Line Data from Clinical Trial for Unyvero Urinary Tract Infection Panel
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Christopher Emery , Johannes Bacher , Indiana University Health Pathology Laboratory , Opgen Inc , Wall Street , Chief Operating Officer , Associate Director , Clinical Microbiology ,