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

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


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)

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Get in Touch with Dako in Australia

  • Pathology Products
    Dako Australia Pty. Ltd.
    +61 2 9922 0700
    +61 2 9922 6657

    A.B.N. 51 067 225 950
    Suite 4, Level 4, 56 Berry Street
    North Sydney
    NSW 2060

  • Flow Cytometry Products and Specific Proteins
    ELITechGroup Australia Pty Ltd
    +61 3 9588 2622
    Freecall: 1 800 815 098
    +61 3 9588 2253

    65 Mills Rd
    VIC 3195

Detailed contact information

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