Oragene Dx DNA Collection Device Gets FDA Clearance

December 9th, 2011 Editors Genetics, Pathology

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

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