Will Sepsitest and Microdx kit transit to IVDR?

Will SepsiTest™-UMD and Micro-Dx™ transit to IVDR?

CE IVD

Yes, both kits will be transferred to IVDR, at the latest in May 2026. Please find Molzym’s statement on the transition to IVDR here.



    • Related Articles

    • Which part of SepsiTest™-UMD or Micro-Dx™ is CE IVD marked?

      CE IVD In brief, from sample to PCR result which resembles the pathogen detection is marked CE IVD. The identification of the pathogens is not included.
    • MicroDx™ CE IVD Product Flyers

      The latest PDF versions of the following Flyers are available for download below: MicroDx™ CE IVD (English) a brief introduction to product features and visual overview of workflow and applications MicroDx™ CE IVD (German) eine kurze Einführung in ...
    • Micro-Dx™ CE IVD Manuals

      The latest versions of the following manuals are available for download below: Micro-Dx™ CE IVD Manual (English) Micro-Dx™ CE IVD Short Manual (English) Micro-Dx™ CE IVD Short Manual (German)
    • SepsiTest™-UMD CE IVD Manuals

      The latest versions of the following manuals are available for download below: SepsiTest™-UMD CE IVD Manual (English) SepsiTest™-UMD CE IVD Short Manual (English) SepsiTest™-UMD CE IVD Short Manual (German)
    • Which organisms have been detected using SepsiTest™-UMD or Micro-Dx™?

      List of microorganisms To date, there are more than 1,300 microbes successfully identified in clinical and other specimens. The complete list you can find here. Bacteria Fungi Acinetobacter baumannii*+ Mycobacterium spp. Aspergillus fumigatus ...