ResourcesVendorsMolecular DiagnosticsBiofire390 Wakara Way Salt Lake City, UT, USA 84108Latest from BiofireFDA ClearanceBioMérieux gets FDA 510(k) clearance, CLIA waiver approval for panelBy LabPulse.com staff writersBioMérieux's Biofire Spotfire Respiratory/Sore Throat Panel has received dual FDA 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver approval.March 27, 2024CandidiasisBioMérieux researchers describe rise of multidrug-resistant Candida auris infectionsBy Elissa WolfsonA retrospective analysis of blood cultures detecting Candida auris found an upsurge of this pathogenic yeast between 2021 and 2023.June 19, 2023Business InsightsWeek in Review: Public Health Emergency ends | BioMérieux nabs FDA CLIA waiver | QuidelOrtho granted de novo requestBy Leo O'ConnorThe FDA this past week continued to grant regulatory approvals for tests associated with COVID-19 that lay outside the scope of the emergency use authorization pathway.May 11, 2023CLIABioMérieux receives FDA CLIA waiver for multiplex PCR respiratory panelBy LabPulse.com staff writersIn about 15 minutes, the panel detects five of the most common viral causes of upper respiratory tract infections: SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus (RSV), and rhinovirus.May 11, 2023
