Bacteromic, a subsidiary of the WSE-listed Scope Fluidics Group, has obtained IVDR certification for the BACTEROMIC system with the UNI Panel. Receiving the certification enables the BACTEROMIC system to be introduced to the European market
The IVDR certificate was granted for the UNI Panel version including all 30 notified antibiotics and the corresponding 56 antibiotic–bacterium (drug-bug) combinations, as well as ESBL resistance mechanism detection and software enabling antimicrobial susceptibility assessment within 16 hours. The number of combinations exceeds the number of antibiotics because, for some of them, susceptibility is assessed across several bacterial groups. At the same time, the Bacteromic team is working on launching the panel for commercial sale.
Simultaneously with obtaining the IVDR Certificate for the UNI Panel and the interpreter, the Bacteromic team confirmed that the devices comprising the BACTEROMIC system, i.e. the analyzer and the filling device, comply with IVDR requirements. As a result, the entire system — analyzer, filling device, interpreter, and UNI Panel — bears the CE marking following the conformity assessment and may be placed on the market in the European Union and in countries that recognize IVDR requirements.
