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Ciphergen s Mass Spec Platform Approved as Medical Device By Chinese Health Authorities

NEW YORK, March 4 (GenomeWeb News) - Ciphergen Biosystems' mass spectrometry-based protein analysis platform has been certified as a medical device by China's State Food and Drug Administration, the company's diagnostics division said today.

 

According to Ciphergen, this is the first time a mass spectrometer has been approved as a medical device in China. The certification opens the door to mass spec-based diagnostic tests, which will have to be approved individually, the company said.

 

"This represents one more step in preparing the ProteinChip System for diagnostic use on a worldwide basis," said Gail Page, president of Ciphergen's diagnostics division.

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