Quality Standards

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

cGMP logo  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
 CE-IVD logo 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. 
 ISO 13485:2016 logo 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. 
 30 years experience conjugated antibody development 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