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2 results on '"Gu WK"'

1. [A pilot study on the quality management system of in-vitro diagnostic reagents].

Author

Liu X, Huang JH, Xu FL, Wang Z, and Gu WK

Subjects
China, Equipment and Supplies standards, Humans, Pilot Projects, Quality Control, Reagent Kits, Diagnostic standards, Safety Management, Technology, Pharmaceutical standards, Total Quality Management, Indicators and Reagents chemistry, Indicators and Reagents standards, Quality Assurance, Health Care organization & administration, Technology, Pharmaceutical organization & administration
Abstract

This article makes a pilot study on the key points of the quality management system of in-vitro diagnostic reagents by analyzing the technical characteristics and production methods of these products as well as the status in quo, and problems the in-vitro diagnostic reagent industry in China is facing nowadays. It can serve as a reference to the supervision departments and the manufacturers in this field which are establishing and running the quality management system.

Published
2006

2. [Studies on administration of in-vitro diagnostic reagents].

Author

Wang Z, Qian H, Xu FL, Huang JH, and Gu WK

Subjects
China, Device Approval, Indicators and Reagents classification, Indicators and Reagents standards, Quality Control, United States, United States Food and Drug Administration, Reagent Kits, Diagnostic classification, Reagent Kits, Diagnostic standards
Abstract

This article introduces the definition, classification, premarket admission and other administering specialities about In-Vitro Diagnostic Reagents in the U.S.A. and China. And by analyzing manufacture and administration of In-Vitro Diagnostic Reagents in our country, It is pointed out that a suitable administering model in accordance with the characteristics of In-Vitro Diagnostic Reagents should be adopted to perfect the administration.

Published
2005

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