Manufacturing Quality

Dako's manufacturing facilities in Denmark and the USA have established quality management systems designed to live up to the most stringent standards in the in vitro diagnostics industry:

International standards:

ISO 9001:2008 Quality Management Systems - Requirements
ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

ISO 9001:2008 (DK)
ISO 13485:2003 (DK)
ISO 9001:2008 (US)
ISO 13485:2003 (US)

Canada:

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

ISO 13485:2003 CMDCAS (DK)
ISO 13485:2003 CMDCAS (US)

European Union:

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

IVD - EC Certificate (DK)

IVD - EC Certificate (US)


The United States:

FDA 21CFR Part 820 Quality System Regulation

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Get in Touch with Dako in United Kingdom

  • Pathology Products
    Dako UK Ltd

    info.uk@dako.com
    +44 (0)1 353 66 99 11
    +44 (0)1 353 66 73 09

    Cambridge House
    St Thomas Place, Ely
    Cambridgeshire CB7 4EX

  • Flow Cytometry Products and Specific Proteins
    Alere Ltd

    ukcustomer@alere.com
    +44 (0)161 483 5884
    +44 (0)161 483 5778

    Pepper Road Hazel Grove
    Stockport, SK7 5BW

Detailed contact information

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