UMD-SelectNA™ CE IVD Manuals

• 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.

• 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)

• 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)

• Add-On 10 CE IVD Manuals

  The latest versions of the following manuals are available for download below: Add-On 10 CE IVD Manual (English) Add-On 10 CE IVD Short Manual (English) Add-On 10 CE IVD Short Manual (German)

• 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.