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DNA Genotek Oragene–Dx collection device wins FDA 510(k) approval

The US Food and Drug Administration (FDA) has granted a 510(k) approval to DNA Genotek's Oragene--Dx collection device.

Oragene–Dx collection device uses a non-invasive method to collect, transport and store DNA samples from saliva for extended periods at ambient temperatures.

The company said its Oragene–Dx device is suitable for use in FDA cleared molecular diagnostic applications and was cleared using results from the eSensor Warfarin Sensitivity Saliva Test.