510(k)
Diasorin Submits Gram-Positive Bacteria Panel for FDA 510(k) Clearance
The Gram-positive blood culture assay is the firm's third panel for the detection and identification of bloodstream pathogens using the Liaison Plex instrument.
Qiagen, Danaher, Thermo Fisher Scientific, Others Gain 510(k) Clearances in October
The US Food and Drug Administration granted clearances for various tests for infectious diseases, coagulation disorders, and drug susceptibility.
Beckman Coulter, T2 Biosystems, Others Gain 510(k) Clearances in September
The US Food and Drug Administration granted marketing clearances for multiple infectious disease tests and a blood culture sample preparation system, among other devices.
FDA Clears Abionic Point-of-Care Sepsis Test
The rapid test is designed to measure blood levels of pancreatic stone protein, which is elevated in sepsis.
Accelerate Dx Gains FDA 510(k) Clearance for Blood Culture Sample Prep Platform
The Accelerate Arc System and BC kit are used for automated positive blood culture sample preparation for downstream microbial identification.