March 2024—Copan Diagnostics announced the third FDA 510(k) clearance for its Colibrí automated ID/AST preparation instrument. The in vitro diagnostic specimen preparation system has been cleared to prepare MALDI-TOF targets for qualitative identification and microbial suspension for the Beckman Coulter MicroScan WalkAway antimicrobial susceptibility testing system for qualitative testing of isolated colonies of Gram-negative and Gram-positive bacterial species grown on solid culture media.
The Colibrí system received 510(k) clearances in 2022 for use with MALDI-TOF mass spectrometry analyzers and the BioMérieux Vitek 2 antimicrobial susceptibility testing system.
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