FDA Gives 501(k) Approval for Oragene Dx Saliva DNA Collection Device

Pennsylvania-based Orasure Technologies announced that its subsidiary, DNA Genotek has received approval to market the Oragene Dx saliva DNA collection device. Orasure revealed that it is the first time that the FDA has given a 510(k) approval for a DNA collection and stabilization device. According to the company, the device is already being used by many academic and research customers in more than 100 countries.

The company also said that the device “provides an all-in-one system for the collection, stabilization, and transportation of DNA from saliva.”

“The clearance further demonstrates our longstanding commitment to produce high quality products that meet the demands of our customers,” said Ian Curry, President of DNA Genotek Inc.


Source-Medindia