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