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

    For the collection of bacterial DNA from fecal samples

    FDA-authorized collection device for microbiome profiling

    OMNIgene•GUT Dx | OMD-200

    OMD-200 Product kit photo

    OMNIgene®•GUT Dx is the first and only FDA-authorized collection device (via De Novo pathway) validated for the self-collection and stabilization of bacterial DNA for gut microbiome profiling.

    Bringing confidence and accuracy to your microbiome discovery

    • Standardize your workflow
    • Simplify your assay development
    • Accelerate your time to market

    The FDA granted the OMNIgene•GUT Dx a De Novo authorization based 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)
    • Usability (Instructions and execution)
    • Compatibility with all sample types (Adult and pediatric cohort)
    Icon link to the complete donor instruction

    View donor user instructions

    Literature

    Data Sheets

    PD-BR-00381: OMNIgene•GUT Dx data sheet (pdf)

    MK-02392: OMNIgene.Gut Dx: Validation for user comprehension and compliance (pdf)

    User Instructions

    PD-PR-01261: Collection of fecal sample using OMNIgene•GUT Dx device (pdf)

    Handbook

    PD-HB-00023: OMNIgene•GUT Dx handbook (pdf)

    Protocols

    PD-PR-00968: Bacterial DNA purification protocol using QIAGEN® QIAamp® PowerFecal® Pro DNA Kit (pdf)

    PD-PR-01415: Storage and aliquoting recommendations for samples collected in OMNIgene™•GUT Dx [OMD-200] (pdf)

    Safety Data Sheets

    PD-MSDS-00036: OMNIgene•GUT Dx MSDS (pdf)

    Accessories

    Toilet Accessory

    Spoon Accessory

    Mailing Accessories

    Customization Options

    all microbiome products listing and product decision tree

    Beyond GUT microbiome

    The OMNIgene® line of products also includes all-in-one systems for quantitative profile analysis of the oral and vaginal microbiome.

    View All Microbiome Collection Devices

    Focus on fecal matters

    OMNIgene•GUT vs. traditional collection

    Overcoming challenges in DNA sample collection.

    Transport and store stabilized DNA at ambient temperature – no cold chain required.

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    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
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        • PERFORMAgene | PG-100
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