bioMérieux receives US FDA 510(k) clearance for its AST System VITEK REVEAL
bioMérieux, announces that its VITEK REVEAL AST System, reporting results directly from positive blood cultures, has received US Food and Drug Administration (FDA) 510(k) clearance
27 Jun 2024
The VITEK® REVEAL™ AST system is an easy-to-use instrument with broad antimicrobial coverage, a small footprint, and a modular design for adaptable throughput, well-suited to address the needs of clinical laboratories. It can deliver actionable results for gram-negative bacteria directly from positive blood cultures in an average of 5.5–6 hours enabling same-day treatment decision-making for patients with bacteremic sepsis.
The FDA 510(k) clearance allows the commercialization of VITEK REVEAL in the United States. The antimicrobial susceptibility testing (AST) system is also CE-marked under In Vitro Diagnostic Directive (IVDD – reagents) and In Vitro Diagnostic Regulation (IVDR – instrument) in Europe.
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