DNA Genotek Files for FDA Clearance of Oragene Products | GenomeWeb

By a GenomeWeb Staff Reporter

NEW YORK (GenomeWeb News) – DNA Genotek announced today that it has field for US Food and Drug Administration clearance of its Oragene Dx family of products.

The Oragene products are used to collect DNA samples from saliva and for isolating and stabilizing DNA for transport and storage.

"We believe that the successful completion of this 510(k) clearance will facilitate broad use of Oragene Dx in molecular diagnostics," DNA Genotek President and CEO Ian Curry said in a statement.

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