Chinese Regulators Clear Affymetrix Platform for Clinical Use | GenomeWeb

This article has been updated from a version posted Feb. 16 to include comments from an Affymetrix official.

By Justin Petrone

China's State Food and Drug Administration has cleared Affymetrix's GeneChip System 3000Dx version 2 for in vitro diagnostic use, Affy said last week.

The system is also cleared for IVD use in the US and Japan and has received a CE-IVD mark in the EU.

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