Add-On 10 CE IVD Manuals

Add-On 10 CE IVD Manuals

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

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    • 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)
    • 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)
    • 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)
    • 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.