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  • Inside DNA Genotek → Quality Policy

    DNA Genotek's product quality

    Customer satisfaction and product quality are very important to DNA Genotek. Our commitment to quality spans all aspects of our internal procedures from customer support to product development and manufacturing. In recognition of the importance of delivering consistent product quality, the company has achieved ISO 13485 certification.

    We apply our ISO accreditation to all of our product and service offerings. Compliance with this standard ensures that our focus continues to be on customer satisfaction and continuous improvement. ISO 13485 is a quality management system standard that is specific to our medical devices. It demonstrates DNA Genotek's compliance with Canadian, US and applicable international regulatory requirements and provides customers with confidence in our medical device products. Maintaining ISO 13485 certification is a top priority for DNA Genotek, and that translates into innovative products that comply with regulations, customer requirements and our own product specifications.

    DNA Genotek is regularly audited by the British Standards Institute (BSI) to ensure that high quality standards are being met in all areas of the business. This includes our design and manufacturing process, our quality control systems, our customer care, administration and management systems.

    At DNA Genotek, we work hard to deliver the right product to our customers at the right time by providing access to accurate, essential information through high quality products, services and solutions. We strive to earn customer loyalty by consistently meeting and exceeding expectations while helping advance health and wellness worldwide. You can find our current Quality Policy, as well as our ISO and MDSAP certifications, below for your reference.

    DNAG Quality Policy

    ISO and MDSAP certifications

    DNAG BSI ISO Certification image link to pdf
    Click to view ISO pdf
    DNAG MDSAP ISO Certification image link to pdf
    Click to view MDSAP pdf

    Inside DNA Genotek

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    Contact us

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    Phone

    +1 (613) 723-5757

    Email

    info@dnagenotek.com

    Address

    3000 - 500 Palladium Drive
    Ottawa, Ontario, Canada
    K2V 1C2

    DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc. (NASDAQ: OSUR), focuses on providing high-quality biological sample collection products and end-to-end services for human genomics, microbiome and infectious disease applications. The Company's Oragene•Dx and ORAcollect•Dx product lines are the first and only FDA 510(k) cleared saliva-based DNA collection devices for in vitro diagnostic use. DNA Genotek also offers Research Use Only products to collect and preserve large amounts of DNA or RNA from multiple sample types. DNA Genotek markets its products worldwide and has a global customer base with thousands of customers in over 100 countries.

    © 2025 DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc., all rights reserved.

  • Industry Solutions
    • Human Genomics - Academic Research
    • Human Genomics - Clinical Diagnostics
    • Microbiome - Academic Research
    • Clinical Microbiome
    • Infectious Disease
    • Metabolomics
    • Biobanking
    • Animal
    • H L A Typing
  • Products
    • Human Genomics
      • All research DNA & RNA collection kits (saliva)
      • Total Nucleic Acids (Host & Microbial)
        • NEW OMNIgene•SALIVA | OMR-610
      • DNA Extraction Reagents
        • prepIT•L2P | PT-L2P (saliva)
        • prepIT•Q2A | PT-Q2A (saliva)
    • Microbiome & Metabolomics
      • All Microbiome & Metabolomics Collection kits
      • Microbiome
        • Oral
          • OMNIgene•ORAL | OM-501 (saliva)
          • OMNIgene•ORAL | OME-505 (saliva)
          • OMNIgene•ORAL | OMR-110 (gum/plaque)
          • OMNIgene•ORAL | OMR-120 (tongue)
        • Skin
          • OMNIgene•SKIN | OMR-140
        • Vaginal
          • OMNIgene•VAGINAL | OMR-130
        • Gut
          • OMNIgene•GUT | OM-200 (feces)
          • OMNIgene•GUT | MP-017
          • OMNIgene•GUT | DNA & RNA | OMR-205
        • Total Nucleic Acids (Host & Microbial)
          • NEW OMNIgene•SALIVA | OMR-610
        • NEW Anaerobe Culture and Media
          • BIOME-Preserve Microbiome Collection Kit
          • Agar Plates
          • Broth Media
          • PRAS Dilution blanks
      • Metabolomics
        • Gut
          • OMNImet•GUT | ME-200
    • Infectious Disease
      • DNA & RNA Collection Kits
        • All DNA & RNA Collection Kits
        • OMNIgene•ORAL | OM-501 (saliva)
        • OMNIgene•ORAL | OME-505 (saliva)
        • Colli-Pee | FV-5000 (urine)
      • DNA Extraction Reagents
        • prepIT•L2P | PT-L2P (saliva)
        • prepIT•Q2A | PT-Q2A (saliva)
    • Animal
      • Animal Microbiome
        • PERFORMAbiome•GUT | PB-200
      • Animal Genetics
        • PERFORMAgene | PG-100
    • Customization Options
      • Branding & Packaging
      • Barcoding
    • Accessories
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    • Customization & Fulfillment
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  • Support
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