- 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)
![The only standardized fecal self-collection device for microbiome discovery authorized by the FDA](../../../../images/landingpages/microbiome/mk-02410_1573x275.png)
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](../../../../images/landingpages/microbiome/OMNIgene-gu-dx.png)
Standardize workflow
Simplify research
Accelerate time to market
Bring confidence and accuracy to your
microbiome discovery
The FDA granted the OMNIgene®•GUT Dx device a De Novo authorization based on a robust validation of:
![OMD-200 Product kit photo](../../../../images/landingpages/microbiome/img-PD-BR-00381.png)
Reduce validation time, experimental bias and failed collections by leveraging the only validated and FDA authorized device for in vitro diagnostic use.
![DNA GENOTEK logo](../../../../images/dna-genotek-logo.png)
![trusted](../../../../images/landingpages/microbiome/trusted-expertise.jpg)
![trusted](../../../../images/landingpages/microbiome/non-invasive-samples.jpg)
![trusted](../../../../images/landingpages/microbiome/pioneering-solutions.jpg)
Inside DNA Genotek
Legal