Beckman Coulter receives IVDR certification covering more than 200 flow cytometry reagents
Leading the way with the industrys largest portfolio of CE-IVD labeled flow cytometry reagents in the market, Beckman Coulter Life Sciences announces that it has received a EU Quality Management System Certificate under the new In Vitro Diagnostic Medical Devices Regulation (IVDR) for more than 200 flow cytometry reagents developed and manufactured at their Marseille, France facility.
The new European In Vitro Diagnostic Regulation 2017/746 (IVDR) is currently set to take effect in May of 2022 and replaces the In Vitro Diagnostics Directive (98/79/EC) (IVDD), which has been followed since 1993. The change can impact European clinical flow cytometry labs, including those using Laboratory-Developed Tests (LDTs).
IVDR 2022 is a marathon -not a sprint -for us as well asclinicallaboratories, said Dr. Mario Koksch, Vice President and General Manager of the companys Flow Cytometry Business Unit. For more than four years, Beckman Coulter Life Sciences has dedicated multiple teams to prepare for this achievement, which further showcases our unique and market-leading position in clinical flow cytometry. We have worked to ensure our existing CE-IVD portfolio, including reagents, kits, software and instruments remain compliant to meet the new regulation. As IVDR compliance also requires significant effort from individual laboratories, we will continue to dedicate resources to help ensure our customers cross the IVDR finish line and reap the benefits.
Additional certifications are expected in the near future. Product availability may vary across regions outside the European Union (EU), including China, India, Japan, and countries that accept the CE mark as the basis for their country-specific registration. Please consult with a Beckman Coulter Life Sciences associate for up-to-the-minute specifications and certifications.
A special resource guide has been established to assist labs at all stages of the IVDR marathon and includes eBooks, whitepapers, and Frequently Asked Questions (FAQs), along with the opportunity to request a one-on-one session with an expert. Simply visit https://www.beckman.com/resources/industry-standards/ivdr.
About Beckman Coulter Life Sciences
Research. Precision manufacturing. If your lifes calling is in any of these or related fields, you need to know Beckman Coulter Life Sciences. Our mission is to empower those seeking answers to lifes important scientific and healthcare questions. Since 1935, the Beckman name has been synonymous with technologies that simplify and automate complex biomedical testing. Decades later, our global organization also came to embody the scientific legacy of the Coulter name. Today, Beckman Coulter Life Sciences is a trusted, worldwide resource for tools to help optimize research and manufacturing efficiency. Centrifuges. Particle counters/analyzers. Automated liquid handlers. Flow cytometers. Genomicreagents. All these productsand many morecontinue to make a difference in peoples lives by improving the productivity of dedicated scientists, quality control experts and others. Wherever people need answers, from prestigious universities and major pharmaceutical companies, to small biotech startups, food/beverage and electronics manufacturing facilities, you can find Beckman Coulter Life Sciences.
For more details, visit beckman.com/contact-us
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