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  • Products → Microbiome → OMNIgene•GUT Dx | OMD-200

    The only standardized fecal self-collection device for microbiome discovery authorized by the FDA

    With over 20 years of trusted experience, DNA Genotek, a subsidiary of OraSure Technologies, Inc., is a leading provider of non-invasive biological sample collection technology. We are pleased to present the OMNIgene®•GUT Dx kit—the first and only FDA authorized collection device (via De Novo pathway) validated for fecal selfcollection and stabilization of bacterial DNA for gut microbiome profiling.

    OMNIgene®•GUT Dx OMD-200

    OMD-200 Product kit photo

    Standardize workflow
    Simplify research
    Accelerate time to market

    Bring confidence and accuracy to your
    microbiome discovery

    Learn More

    The FDA granted the OMNIgene®•GUT Dx device a De Novo authorization based on a robust validation of:

    • Sample stability (30 days at room temperature)
    • Sample neutrality (unbiased representation of the in vivo state)
    • Reproducibility (lot-to-lot and aliquot-to-aliquot)
    • Easy to use for improved donor compliance
    • Compatibility with all sample types (adult and pediatric cohorts)
    OMD-200 Product kit photo

    Reduce validation time, experimental bias and failed collections by leveraging the only validated and FDA authorized device for in vitro diagnostic use.

    Learn more by reading this data sheet

    Sample / Quote Request

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    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
    • Microbiology/Infectious Disease
    • Metabolomics
    • Biobanking
    • Animal
    • H L A Typing
  • Products
    • Human Genomics
      • All clinical DNA collection kits (saliva)
      • All research DNA & RNA collection kits (saliva)
      • Total Nucleic Acids (Host & Microbial)
        • NEW OMNIgene•ORAL | OMR-610
      • DNA Extraction Reagents
        • prepIT•L2P | PT-L2P (saliva)
        • prepIT•Q2A | PT-Q2A (saliva)
    • Microbiome & Metabolomics
      • All Microbiome & Metabolomics Collection kits
      • Microbiome (IVD)
        • Gut
          • NEW OMNIgene•GUT DX | OMD-200 (IVD)
      • Microbiome (Research only)
        • Gut
          • OMNIgene•GUT | OMR-200
          • OMNIgene•GUT | MP-018
          • OMNIgene•GUT | DNA & RNA | OMR-205
        • Skin
          • OMNIgene•SKIN | OMR-140
        • Vaginal
          • OMNIgene•VAGINAL | OMR-130
        • Oral
          • OMNIgene•ORAL | OM-501 (saliva)
          • OMNIgene•ORAL | OMR-110 (gum/plaque)
          • OMNIgene•ORAL | OMR-120 (tongue)
        • Total Nucleic Acids (Host & Microbial)
          • NEW OMNIgene•SALIVA | OMR-610
        • NEWAnaerobe Culture and Media
          • BIOME-Preserve Microbiome Collection Kit
          • Agar Plates
          • Broth Media
          • PRAS Dilution blanks
      • Metabolomics
        • Gut
          • OMNImet•GUT | ME-200
    • Infectious Disease
      • COVID-19
        • COVID-19 Collection Kits
        • OMNIgene•ORAL | OME-505 (saliva)
      • DNA & RNA Collection Kits
        • All DNA & RNA Collection Kits
        • OMNIgene•ORAL | OM-501 (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
      • Collection
      • Mailing
  • Services
    • Customization & Fulfillment
      Product customization and direct-to-donor shipments
  • Support
    • Collection Instructions
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    • FAQs
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    • Contact Tech Support
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