Oragene™•Dx saliva collection device

Name: Oragene™•Dx saliva collection device
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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.