Oragene Dx DNA Collection Device Gets FDA Clearance

DNA Genotek, a subsidiary of OraSure Technologies, received FDA clearance to market the Oragene Dx saliva DNA collection device. According to the company this is the first 510(k) approval for a DNA collection and stabilization device.

The device promises reliable collection of DNA samples and the ability to use it to transport and store the samples for an extended time period.

• Painless, non-invasive collection

• Median A260/280 of 1.7‡

• Easy collection and transportation

• Oragene•Dx/saliva samples are stable for long-term room temperature storage

• Standardized tube format

• Oragene•Dx solution is bacteriostatic

Press release: OraSure Technologies Subsidiary, DNA Genotek Receives FDA 510(k) Clearance for Oragene(R) Dx Collection Device

Product page: Oragene•Dx