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In recent years altona Diagnostics has made preparations for the original date of application (May 26, 2022) of the European Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). In October 2021, extended transition periods were proposed by the European Commission. Nevertheless, we go forward with our IVDR projects regarding our AltoStar® kits. On Dec 20, 2021, eighteen AltoStar® (RT-)PCR kits and sample preparation reagents are relaunched.
New product numbers and Global Trade Item Numbers (GTIN) are assigned to the relaunched AltoStar® products, which are designed to fulfill IVDR requirements. The kits offer the same high quality which applies to all products from altona Diagnostics and are chemically identical to their already existing counterparts.
The new AltoStar® kits are validated for automated use with the CFX96 Deep Well Dx System, which is part of the AltoStar® Workflow. An additional advantage is that they are validated for manual use with different other real-time PCR instruments. This allows their use by customers who have not yet made the transition to our AltoStar® Molecular Diagnostic Workflow.
altona Diagnostics GmbH
Mörkenstr. 12
22767 Hamburg, Germany