Ciphergen Biosystems, Inc.

ProteinChip system receives medical device certification in China

Published in Drug Law Weekly, April 6th, 2004

The Ciphergen Diagnostics Division of Ciphergen Biosystems, Inc., (CIPH) announced that the ProteinChip System has been certified (certificate number SFDA(I) 20032400768) by the State Food and Drug Administration (SFDA) in China as a medical device, a result of demonstrating that the ProteinChip System has met the quality control requirements of the SFDA.

This is the first step required to delivering diagnostic tests in China using the ProteinChip System and it is the first time that a mass spectrometer has been approved as a medical device in China. Future individual diagnostic tests will have to be individually cleared by the SFDA based on their performance in...

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Source: Drug Law Weekly (2004-04-06)

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