Bruker has made IVD MALDI Biotyper available for sale as a Class 1 Medical Device to all clinical microbiology sites in Canada after meeting the relevant Health Products and Food Branch (HPFB) of Health Canada regulations.
The MALDI Biotyper, a MALDI-TOF mass spectrometry based bench-top platform for rapidly identifying bacteria and yeasts, is available in a research-use-only version, as well as in the IVD MALDI Biotyper IVD-CE version according to EU directive EC/98/79 in certain European countries.
Optionally, the IVD MALDI Biotyper is also available in combination with the i2A SirWeb-MALDITOF software as a fully integrated solution for clinical microbiology laboratories.
Its carefully curated database includes quality-controlled entries of over 3,900 strains from over 2,000 well-characterized microbial species.
The MALDI Biotyper offers faster time-to-result (TTR), high specificity, very low false positive rates, low operational costs, and low technical barriers for new operators, the company said.
Bruker MALDI Biotyper executive director George Goedesky said the IVD MALDI Biotyper offers clinical microbiologists an opportunity to reduce turn-around time, time-to-result and improve identification accuracy with an efficient, cost effective modern, molecular method.
i2a Canada is the exclusive sub-distributor of the Bruker IVD MALDI Biotyper.