DNA Genotek Gets FDA Clearance for Sample Collection Device | GenomeWeb

NEW YORK (GenomeWeb) – DNA Genotek announced today that it has received 501(k) clearance from the US Food and Drug Administration for its sample collection device, an alternative to buccal swabs that enables makers of molecular diagnostic devices and laboratory developed tests to reduce the time and regulatory burden associated with their FDA submissions.

The device, the ORAcollectDx, is part of DNA Genotek's OrageneDx saliva-based DNA collection and stabilization devices.

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