DNA Genotek’s Oragene•Dx family of products are the first and only devices with U.S. Food and Drug Administration (FDA) general use 510(k) clearance for collection and stabilization of DNA from saliva for use in genetic testing of human germline DNA, including for prescription or over-the-counter (direct-to-consumer) use. In addition Oragene•Dx is suitable for use by individuals of all ages, including for pediatric use.
A time and cost savings
This 510(k) clearance allows test manufacturers to immediately use this device in either a prescription or direct-to-consumer model – where collection can be done by either a healthcare professional or non-healthcare professional including a lay user. General clearance also allows discussing more customer-friendly options in regards to customizations. For test manufacturers seeking FDA clearance, this will save both time and money compared to re-validating other devices that are not FDA cleared for general use.
Backed by a decade of experience and customer support
We have nearly a decade of experience and knowledge supporting genetic test providers through their own FDA clearances. Customer success is our first priority which is why we provide our customers with regulatory and product and marketing support for their own 510(k) submissions, ensuring a faster and more affordable path to clearance.
We also offer professional customization, branding and order fulfillment services to those interested in streamlining their sample workflow. We provide advice on project design, workflow integration, sample preparation, extraction technology recommendations, sample analysis, shipping logistics and storage best practices.
Trusted by 6,000 customers in over 100 countries
DNA Genotek has a strong legacy as an industry leader in product innovation, sample quality and customer service. There is a reason why 10 of the top 10 US hospitals, 20 of the top 20 global universities, hundreds of genetic testing companies and the largest personalized genetic companies in the world choose our products. More than 6,000 customers in over 100 countries trust and use our products to enable their genetic testing or research projects.
If you would like to learn more about our Oragene•Dx family of products, end to end service offerings or would like to evaluate for yourself please contact us at firstname.lastname@example.org and allow us the opportunity to exceed your expectations.