WebApr 7, 2024 · - The Unyvero Invasive Joint Infection, or IJI, test, which is a variant of the ITI cartridge test specifically being developed for the U.S. market, has also been selected for analytical and ... WebApr 3, 2024 · Device Classification Name. lower respiratory microbial nucleic acid detection system. 22. De Novo Number. DEN170047. Device Name. Curetis Unyvero LRT Application. Requester.
Curetis Completes Sample Enrollment in Unyvero U.S. FDA Trial in …
WebFeb 21, 2024 · The Unyvero LRT BAL panel is the only FDA-cleared molecular diagnostic that includes Pneumocystis jirovecii, the causative agent of P. jirovecii pneumonia.As culture-based diagnosis of P. jirovecii pneumonia is not possible, identification of this pathogen is often based on morphological detection techniques, which are labor … WebThe Unyvero LRT panel approach simultaneously identifies a broad spectrum of clinically relevant pathogens and antibiotic resistance markers associated with lower respiratory … csl dd firmware update
OpGen Subsidiary Curetis and FIND Sign R&D Collaboration
WebJan 18, 2024 · Following successful completion of patient sample enrollment into the Unyvero Urinary Tract Infection (UTI) clinical trial in the U.S., OpGen completed its initial analysis and published strong top-line data with an overall weighted average sensitivity of 96.4% and an overall weighted average specificity of 97.4%. The Company also initiated … WebGerman KfW bank in September 2024 for its Unyvero A30 RQ platform for LMICs. FIND committed to invest €700k in the initial pilot study with an option to extend the collaboration, including a potential commercialization agreement. In the feasibility phase, OpGen, through its German subsidiary Curetis, is to develop a molecular WebJun 4, 2024 · Curetis' Unyvero System is a versatile, fast and highly automated molecular diagnostic platform for easy-to-use, cartridge-based solutions for the comprehensive and rapid detection of pathogens ... csl dd force feedback settings