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BacterioScan 216Dx System is an FDA 510(k)-cleared IVD device utilizing laser scattering technology for rapid Urinary Tract Infection (UTI) detection and Antimicrobial Susceptibility Testing (AST) in 3 hours, boasting >97.7% sensitivity. This significantly reduces diagnosis time compared to traditional 24-30 hour methods, enabling faster antibiotic stewardship and a substantial reduction in unnecessary antibiotic prescriptions by providing rapid negative predictive value for 60-90% of UTI tests.
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