Curetis’ urinary tract infection test cartridge gained a CE Mark for diagnosing severe UTIs.

The polymerase chain reaction-based cartridge uses the company’s Unyvero system, which was cleared by the FDA earlier this month.

The cartridge covers 103 diagnostic targets, detecting 88 pathogens — including Gram-positive and Gram-negative species, anaerobic bacteria and the pathogenic fungus Candida auris — and 15 genetic markers of antibiotic resistance.