Micro-Dx™ CE IVD Manuals

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• 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)

• MolYsis-SNplus™ IVD Manuals

  The latest versions of the following manuals are available for download below: MolYsis-SNplus™ IVD Manual (English) MolYsis-SNplus™ IVD Short Manual (English)

• 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.

• Will SepsiTest™-UMD and Micro-Dx™ transition 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.