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News

China Medical receives CE Mark for semi-automatic ECLIA analyser duo

China Medical Technologies : 24 March, 2008  (New Product)
China Medical Technologies has received the CE Mark for the company’s two semi-automatic ECLIA analysers and 15 reagents.
Under the In-Vitro Diagnostic Directive (IVDD) of the European Union (EU), products must meet regulatory requirements in order to qualify for sales and distributions in the EU. A CE Mark indicates that a product complies with the EU regulatory requirements. The company receives the CE Mark for its two semi-automatic ECLIA analysers and 15 reagents, including thyroid disorders, diabetes and tumour marker reagents.

'The CE Mark demonstrates that our products meet the IVDD requirements,' said Xiaodong Wu, chairman and chief executive officer of China Medical Technologies. 'It not only allows us access to new markets but also strengthens our leading position in the advanced IVD market in China.'

ECLIA system is a closed IVD system including an analyser and reagents that are used to detect and quantify particular antibodies or antigens for the diagnosis and analysis of various diseases and disorders. The company will continue to work on receiving CE Mark for its other ECLIA reagents.
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