Pioneering IVDR Compliance for Flow Cytometry
Beckman Coulter Life Sciences has taken a groundbreaking step in the field of flow cytometry by introducing an unprecedented range of IVDR-compliant reagents. With over 270 reagents now available, laboratories can confidently prepare for the upcoming In Vitro Diagnostic Medical Devices Regulation (IVDR) well ahead of the May 2024 deadline set by the European Union.
Empowering Laboratories with IVDR-Ready Solutions
Recognizing the critical need for laboratories to transition smoothly to IVDR compliance, Beckman Coulter Life Sciences has proactively expanded its manufacturing capabilities. With certified sites in France, Ireland, China, India, and the United States, the company ensures uninterrupted supply of essential reagents.
Unveiling the IVDR Advantage
The IVDR regulations aim to enhance the safety and efficacy of in vitro diagnostic products, replacing the outdated In Vitro Diagnostics Directive (98/79/EC) (IVDD). This transition significantly impacts laboratories utilizing Laboratory-Developed Tests (LDTs) or ‘in-house IVDs’, which constitute the majority of clinical flow cytometry tests.
Timely Guidance for Seamless Implementation
Beckman Coulter Life Sciences understands the complexities of IVDR compliance and offers a comprehensive resource guide. This invaluable resource includes eBooks, whitepapers, FAQs, and expert consultations, empowering laboratories to navigate the transition with confidence.
Expert Insights on IVDR Compliance
Dr. Andreas Böehmler, Director of Clinical Solutions Product Management for the Global Flow Cytometry Business Unit, emphasizes the importance of timely action. He advises laboratories to initiate the compliance process immediately to avoid potential disruptions and costly shutdowns.
Beckman Coulter Life Sciences: A Trusted IVDR Partner
As one of the few reagent providers listed on the official European Database on Medical Devices (EUDAMED), Beckman Coulter Life Sciences demonstrates its commitment to IVDR compliance. Its IVDR portfolio is readily searchable under its manufacturing site in Marseille, Immunotech SAS.
IVDR-Compliant Antibodies for Comprehensive Analysis
Beckman Coulter Life Sciences’ IVDR-compliant single-colour antibodies are designed for use in multicolour panel design. These antibodies facilitate the diagnosis, monitoring, and prognosis of patients with various health conditions, including hematological abnormalities, neoplasms, disorders, immunodeficiencies, and autoimmune diseases.
Global Availability and Regulatory Compliance
While product availability may vary in regions outside the EU, Beckman Coulter Life Sciences ensures compliance with local regulations in China, India, Japan, and countries that accept the CE mark.
With Beckman Coulter Life Sciences as your trusted partner, laboratories can confidently embrace the future of flow cytometry, knowing that they are equipped with the highest quality IVDR-compliant reagents and expert guidance.
