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Utah Life Sciences News & Events

ELITechGroup achieves a new CE-IVDR Certification

June 6, 2024

  • ELITechGroup continues to expand its portfolio of IVDR-certified PCR assays to support European diagnostic laboratories
  • The newly obtained IVDR certificate will expedite the transition to IVDR for quantitative Class C infectious diseases assays
  • The company is fully committed to delivering its entire portfolio of nearly 60 molecular assays as IVDR compliant by 2026

Turin, Italy – May 29, 2024 – ELITechGroup is pleased to announce that they have obtained the IVDR certification for four new products including the brand new CMV RNA ELITe MGB Kit.
With the acquisition of this certification, ELITechGroup continues accelerating IVDR transition for the class C products for infectious diseases. This class includes all quantitative tests for infectious diseases follow up in transplant patients, such as the ELITe MGB CMV monitoring assay.

This significant milestone underscores ELITechGroup’s commitment to delivering high-quality and reliable diagnostic solutions to healthcare professionals worldwide. This achievement not only validates the rigorous standards the company adheres to in its product development but also reinforces its dedication to improving patient care through advanced diagnostic technologies.

ELITechGroup continues to lead the way in the development and commercialization of innovative diagnostic solutions, ensuring compliance with the highest regulatory standards.

About ELITechGroup 

ELITechGroup, part of Bruker Corp.,is an integrated in-vitro diagnostics company that serves hospitals and diagnostic laboratories in more than 100 countries. The company develops, manufactures, and markets a wide range of diagnostic products and solutions – instruments, reagents, and software.

ELITech Molecular Diagnostics (MDx) serves the needs of clinical and research laboratories by offering a wide range of molecular diagnostic products, including nearly 60 CE-IVD assays and instruments as well as software applications.