Oragene™•Dx saliva collection device
Place your order directly with the manufacturer.
Collect high quality DNA samples for molecular diagnostics with an FDA cleared device.
- U.S. FDA 510(k) general clearance for prescription (Rx) and direct-to-consumer (DTC) uses
- Leveraging the 510(k) clearance of Oragene™•Dx device may reduce the time and complexity of an FDA submission
- All-in-one system for the collection, stabilization and transportation of DNA from saliva
- Painless, minimally-invasive and easy-to-use DNA sample device for self collection
Device / Assay manufacturers must validate the use of this device for their specific indications for use.
Why consider an FDA-cleared device for your genetic tests and molecular diagnostics
The Oragene™•Dx and ORAcollect™•Dx devices have US FDA 510(k) general clearance for prescription and over-the-counter (direct-to-consumer) uses. This designation allows this device to be used by commercial partners and legally marketed with their therapeutics or devices in conjunction with their product's intended use. Discover how an FDA-cleared device may offer advantages such as:
- Validated performance and ease of use
- Reduced timeline to validate your Laboratory Developed Assay (LDT)
- Cost-effective market path for your genetic test
- Reduced regulatory burden when filing an FDA submission for your assay
- Customization offerings for your test (branding and fulfillment services)
Sample collection instructions for the Oragene™•Dx device
Learn how to easily and safely collect a saliva sample using the Oragene™•Dx device. This in vitro diagnostic device is FDA-cleared for prescription and over-the-counter use, providing a non-invasive way to collect, stabilize, and transport human DNA from oral samples.
In this step-by-step guide, we show you how to:
- Prepare for sample collection
- Use the kit’s funnel and stabilization solution correctly
- Deliver the right amount of saliva to reach the fill line
- Secure and mix the sample for safe transport
- Ship the sample according to biological specimen regulations
The process takes just 2–5 minutes and ensures your DNA sample remains protected until analysis. Perfect for anyone looking for a convenient and reliable DNA collection method at home.
