Ecoli Dx News eSens PCR kits of IVD-R group D change to RUO

eSens PCR kits of IVD-R group D change to RUO

10.12.2025

Dear partners,

We have thoroughly assessed the situation arising from the requirements set out in the legislation for continuing to place so-called legacy IVDDs (i.e., products that meet the requirements of Article 110 of the IVDR) on the market and have made the following decisions:

Unfortunately, we will no longer supply products from our portfolio that are classified in group D according to IVDR criteria (see attached list) as IVDs.

  • ES3301B eSens Influenza virus A/H5N1 QL PCR kit
  • ES3312A eSens NA SARS-CoV-2/SARS-CoV Multiplex
  • ES3603B eSens CCHFV QL PCR kit
  • ES3604B eSens EBOV Zaire QL PCR kit
  • ES3640B eSens Plasmodium sp./falciparum/vivax QL PCR kit
  • ES3806B eSens Bacillus anthracis QL PCR kit

With regard to other legacy IVDDs (i.e., those that will fall under Class B and Class C according to IVDR criteria), we have decided to take steps to meet the above requirements for their continued marketing within the maximum time limits allowed by the IVDR.

Please download the updated version of the in the eSens Marketing Materials folder in the Downloads section.

Thank you for your understanding.

Your Ecoli Dx team

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