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 New Zealand

  • Pathology Products
    Please inquire at
    Dako Australia Pty. Ltd.

    customercarenz@dako.com
    +61 3 9357 0892
    +61 3 9357 0896
    Toll Free Phone: 0800 403 254
    Toll Free Fax: 0800 403 693

    A.B.N. 51 067 225 950
    8 The Crossway
    Campbellfield
    VIC 3061
    Australia

  • Flow Cytometry Products and Specific Proteins
    Vital Diagnostics

    info@vitaldiagnostics.com
    +61 2 9894 6988
    Freecall: 1 800 815 098
    +61 2 9899 6303

    5/18 Lexington Dr Bella Vista NSW 2153
    189 - 199 Browns Rd
    Noble Park
    VIC 3174

Detailed contact information

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