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Oragene•DNA is now Oragene•DISCOVER for US research customers

Posted by Ian Curry on Tue, Feb 14, 2012 @ 09:02 AM

Oragene DNA Oragene DISCOVERWe would like to introduce you to Oragene•DISCOVER, a new brand for our research customers within the United States. Oragene•DISCOVER is the result of a change in the brand name and labeling of our Oragene•DNA product. Here are some of the reasons why we made this change and what we think it means for you.

Why we made this change

DNA Genotek is introducing the Oragene•DISCOVER line of products within the United States to differentiate it from our new Oragene•Dx line of products that is intended for diagnostic use within the United States. Oragene•Dx products are FDA 510(k) cleared (class II) medical devices[1].

What it means for you

There will be no change to pricing, manufacturing specifications or performance characteristics for these products. As such, it is not necessary to re-validate your extraction method or downstream analysis with the Oragene•DISCOVER product line. The product labeling will specify that the product is For Research Use Only and not for use in diagnostic procedures.

The new product numbers will be as follows:

  • Oragene•DISCOVER OGR-500 (previously Oragene•DNA OG-500)
  • Oragene•DISCOVER OGR-575 (previously Oragene•DNA OG-575)
  • Oragene•DISCOVER OGR-250 (previously Oragene•DNA OG-250)

You can read the formal Product Change Notification about this change and you can subscribe to our blog (link) to get regular updates. Our web site has already been updated with these newly branded products and has been regionalized so that you will see only the products available in your region. Please visit www.dnagenotek.com for all product information.

What’s next?

DNA Genotek academic research customers in the United States will continue to receive the great service and support you’ve come to expect for the Oragene•DNA products you have on hand. Any future orders placed for academic research products will be fulfilled with the Oragene•DISCOVER branded product.

If you require further information about this branding change or have questions or concerns, please do not hesitate to contact your Account Manager at 1-866-813-6354 or send us an email at info@dnagenotek.com.

As always, thank you for being part of the DNA Genotek community by using our products to further genetic research using Oragene.

[1] FDA cleared for in vitro diagnostic use with the eSensor® Warfarin Sensitivity Saliva Test.


Tags: 510(k), Oragene DNA, Oragene DISCOVER

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This blog is intended to provide information to educate readers about molecular testing and genetic sample collection and DNA Genotek products.  Some of the information on this blog represents emerging scientific research or data developed for research purposes only. More information here.

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Welcome to The Genetic Link, a blog providing new insights into DNA and RNA sample collection by DNA Genotek. DNA Genotek is a subsidiary of OraSure Technologies, Inc.

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