Studies on administration of in-vitro diagnostic reagents.
- Author:
Ze WANG
1
;
Hong QIAN
;
Feng-Ling XU
;
Jia-Hua HUANG
;
Wei-Kang GU
Author Information
1. Shanghai Municipal Drug and Medical Device Evaluation Center.
- Publication Type:Journal Article
- MeSH:
China;
Device Approval;
Indicators and Reagents;
classification;
standards;
Quality Control;
Reagent Kits, Diagnostic;
classification;
standards;
United States;
United States Food and Drug Administration
- From:
Chinese Journal of Medical Instrumentation
2005;29(2):124-130
- CountryChina
- Language:Chinese
-
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.
