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      • All DNA & RNA Collection Kits (saliva)
      • Oragene•DNA | 600 Series
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      • OMNIgene•GUT | OM-200 (feces)
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      • NEW OMNIgene•ORAL | OME-505 (saliva)
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      • NEW OMNIgene•ORAL | OME-505 (saliva)
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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 both ISO 9001 and ISO 13485 certification.

    We apply ISO 9001 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.

    Quality Policy

    Our global policy is to provide superior quality products and services that contribute to significant improvements to global human health. We will:

    • Build customer loyalty by continuously meeting or exceeding their expectations through innovation, service, value and compliance with applicable laws and regulations.
    • Continually improve and maintain the effectiveness of our quality system by establishing, implementing and monitoring quality objectives.

    Inside DNA Genotek

    • Company overview
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    • Genetic testing fraud alert ⚠

    Contact us

    • Contact DNA Genotek
    • International Distributors

    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.

    © 2021 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
    • Biobanking
    • Animal
    • H L A Typing
  • Products
    • Human Genomics Collection Kits
      • Academic Research
        • All DNA & RNA Collection Kits (saliva)
          • Oragene•DNA | 600 Series
          • Oragene•DNA | 500 Series
          • ORAcollect for Pediatrics | OC-175
          • Oragene•RNA | RE-100
      • Clinical Diagnostics
        • All DNA Collection Kits (saliva)
          • Oragene•DNA | 600 Series
          • Oragene•DNA | 500 Series
          • Oragene•ONE | ON-600
          • Oragene•ONE | ON-500
          • ORAcollect•DNA | OCR-100
      • Reagents
        • prepIT•L2P | PT-L2P (saliva)
        • prepIT•Q2A | PT-Q2A (saliva)
        • HEMAgene | HG-BCD (blood)
    • Microbiome Collection Kits
      • Academic Research
        • All microbiome products list
        • OMNIgene•GUT | OM-200 (feces)
        • OMNIgene•GUT | OM-200.100 (collection kit)
        • OMNIgene•ORAL | OM-501 (saliva)
        • OMNIgene•ORAL | OM-505 (saliva)
        • OMNIgene•ORAL | OMR-110 (gum/plaque)
        • OMNIgene•ORAL | OMR-120 (tongue)
        • OMNIgene•VAGINAL | OMR-130
        • NEWOMNIgene•SKIN | OMR-140
      • Clinical Microbiome
        • OMNIgene•GUT | OM-200 (feces)
    • Infectious Disease Collection Kits
      • NEWCOVID-19 Collection Kits
      • All DNA & RNA Collection Kits
        • COVID-19 Collection Kits
        • OMNIgene•ORAL | OM-501 (saliva)
        • OMNIgene•ORAL | OM-505 (saliva)
      • Reagents
        • prepIT•L2P | PT-L2P (saliva)
    • Animal Collection Kits
      • PERFORMAbiome•GUT | PB-200
      • PERFORMAgene | PG-100
    • Customization Options
    • Accessories
  • Services
    • Microbiome
      Amplicon and whole genome sequencing and analysis
    • Customization & Fulfillment
      Product customization and direct-to-donor shipments
  • Support
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  • Learn
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  • Inside DNA Genotek
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    • Careers
    • Press releases
    • News articles
    • Testimonials
    • Conferences
    • Seminars
    • Webinars
    • Quality Policy
  • Programs
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