Curetis said today that it won CE-IVD marking for its Unyvero cartridge designed to diagnose severe urinary tract infections. The cartridge covers 103 diagnostic targets and can detect 88 pathogens, according to Curetis, including a multi-drug-resistant pathogenic fungus that is of particular concern to hospitalized patients with compromised immune systems. Unyvero UTI can also detect […]
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Curetis wins FDA nod for respiratory infection diagnostic system
Molecular diagnostics company Curetis said today that it won a de novo clearance from the FDA for its Unyvero System and lower respiratory tract infection cartridge. Combined with the cartridge, the Unyvero System evaluates samples for the presence of infectious respiratory disease in under five hours. The device can also tell doctors if it detects any […]