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Collect high quality DNA samples for molecular diagnostics with an FDA cleared device.

Genetic testing and personalized medicine starts with the collection of DNA samples. Use Oragene®•Dx for proven collection, stabilization and transportation of DNA from saliva.

Oragene•Dx:

  • First and only Saliva DNA Collection and Stabilization Device to Receive 510(k) Clearance†
  • Oragene•Dx has been cleared for in vitro diagnostic use in the U.S.A.
  • Painless, non-invasive collection
  • Easy collection and transportation
    • Saliva samples are stable for long-term room temperature storage
    • Standardized tube format
    • Solution is bacteriostatic

Securing FDA 510(k) clearance of Oragene•Dx ensures that clinical diagnostic and personalized medicine test providers can now experience the benefits of Oragene using a family of products cleared for use by the FDA. This FDA clearance will provide added flexibility to diagnostic customers who wish to offer their patients the non-invasive, reliable and easy-to-use Oragene•Dx saliva sample collection device as an alternative to invasive blood collection. In addition, the FDA 510(k) clearance of Oragene•Dx will enable molecular diagnostic test manufacturers to streamline their own regulatory submissions and potentially broaden market accessibility for their genetic tests.

Download the Clinical Genetic Testing data sheet.

Download the Personalized Medicine data sheet.

For in vitro diagnostic use. For collection of human DNA.
† FDA cleared for in vitro diagnostic use with the eSensor® Warfarin Sensitivity Saliva Test.

Full terms and conditions for all DNA Genotek products are available here.

Featured Products

Oragene•DX (OGD-510)
1 mL sample for single test applications

Genetic testing starts with the collection of DNA samples. Use Oragene•Dx® for proven collection, stabilization and transportation of DNA from saliva. Oragene•Dx is an FDA cleared device.

Oragene•DX (OGD-510)

 

Oragene•DX (OGD-500)
2 mL sample to maximize DNA yield for complex tests

Genetic testing starts with the collection of DNA samples. Use Oragene•Dx® for proven collection, stabilization and transportation of DNA from saliva. Oragene•Dx is an FDA cleared device.

Oragene•DX (OGD-500)

 

Oragene•DX (OGD-575)
0.75 mL sample for assisted collection

Genetic testing starts with the collection of DNA samples. Use Oragene•Dx® for proven collection, stabilization and transportation of DNA from saliva. Oragene•Dx is an FDA cleared device.

Oragene•DX (OGD-575)

 

Full terms and conditions for all DNA Genotek products are available here.


DNA Genotek's sample collection devices and nucleic acid stabilization chemistries are protected by issued and pending patents in numerous countries around the world.
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