www.fdanews.com/articles/206094-copans-colibri-automated-specimen-workup-instrument-gets-510k-clearance
Copan’s Colibri Automated Specimen Workup Instrument Gets 510(k) Clearance
January 10, 2022
Murrieta, Calif.-based Copan Diagnostics’ Colibri automated processor, an addition to the company’s WASPLab laboratory automation system, has received the FDA’s 510(k) clearance.
Colibri is used in conjunction with bioMérieux’s Vitek MS or Bruker’s Maldi Biotyper CA mass spectrometry systems to automate the rapid identification of colonies of Gram-negative and Gram-positive bacteria grown on solid culture media.
The device is intended to be paired with Copan’s artificial intelligence software, PhenoMATRIX, to automate “a crucial step in diagnostic microbiology,” according to the company.