Manufacturing Quality

Unsurpassed international manufacturing capabilities

Reagent Partnership Division utilizes flexible, large-scale, automated filling and packaging manufacturing facilities for production hosting of monoclonal and polyclonal primary and secondary antibodies, and assay development for turbidimetry platforms.

Compliance with the most stringent industry standards

State-of-the-art manufacturing facilities in Denmark and the United States provide established quality management systems designed to comply with the most stringent standards in the in vitro diagnostics industry.

International standards:
ISO 9001:2000 Quality Management Systems – Requirements
ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

Canada:
SOR/98-282 Canadian Medical Device Regulations (CMDR)

European Union:
98/79/EC (IVD Directive), Annex IV: EC Certificate - Full Quality Assurance Certificate

United States:
FDA 21CFR Part 820 Quality System Regulation

For more information, please contact reagent.partnerships@dako.com