altona Diagnostics announces that its FlexStar® STI panel has obtained CE marking under Regulation (EU) 2017/746 (IVDR). This milestone completes the IVDR transition for the company’s modular & adaptive STI testing portfolio, enabling laboratories to configure customizable multiplex panels for up to 7 sexually transmitted pathogens in a single sample.
altona Diagnostics GmbH announces the opening of altona Diagnostics México S. de R.L. de C.V., it’s 10th global location and another highlight in the company’s success story.
altona Diagnostics today announced the launch of the RealStar® Bundibugyo Virus RT PCR Kit 1.0 (RUO), a dedicated real-time RT-PCR assay for specific detection of Bundibugyo virus RNA to support filovirus research and outbreak-related investigation workflows. The launch comes in response to the ongoing Ebola disease outbreak caused by Bundibugyo virus in the Democratic Republic of the Congo and Uganda.
altona Diagnostics provides two solutions for the detection of the current Bundibugyo virus variant: For detection: The “RealStar® Filovirus Screen RT-PCR Kit 1.0”, available as CE-IVD marked and as a RUO (research use only) version. For typing: The “RealStar® Filovirus Type RT-PCR Kit 2.0”, available as a RUO (research us only) version.
altona Diagnostics has announced that the CE-IVD marking under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) for all AltoStar® PCR kits intended for monitoring of transplant patients will be completed during spring 2026. This milestone illustrates altona Diagnostics’ long-term commitment to regulatory excellence and clinical reliability.
altona Diagnostics GmbH announces the launch of the AltoStar® HDV RT-PCR Kit 1.5 (CE-IVD), a new PCR test for the detection and quantification of hepatitis delta virus (HDV) specific RNA in human EDTA plasma and serum. This launch marks a unique milestone in molecular diagnostics: altona Diagnostics now provides the first and only complete automated CE-IVD PCR portfolio covering all five hepatitis viruses (A, B, C, D, and E).
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