Beckman Coulter flow cytometry teams are committed to develop and manufacture reagents with the highest quality standards in the industry. Our flow cytometry reagents cover a wide range of specificities compliant with high requirements regulatory status (RUO [cGMP], ASR, CE-IVD, IVD), ensuring robust and optimal clinical panel design for the most relevant flow cytometry applications
|Development and production of our conjugated antibodies under current Good Manufacturing Practices (cGMP) in facilities that adhere and are certified to the highest standards in the industry
|Offering the broadest ASR and CE-IVD clone and reagents portfolio in over 60 countries worldwide, following the most strict regulations such as the European Directive (98/79/EC) for CE-IVD antibodies and the United States FDA-related 21 CFR 864.4020 and 21 CFR part 820 for Medical devices for ASR and IVD antibodies.
|Manufacturing is done exclusively in sites that are ISO 13485:2016/ 9001:2015 compliant, demonstrating the continuous evolution of Beckman Coulter’s quality management systems (QMS) and processes.
|Having more than 30 years of experience in conjugated antibody development and manufacturing, associated with the strictest internal quality controls that demonstrate lot-to-lot consistency over time in all our products