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 ...