[Studies on administration of in-vitro diagnostic reagents].
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.
Wang
Ze
Z
Shanghai Municipal Drug and Medical Device Evaluation Center.
Qian
Hong
H
Xu
Feng-Ling
FL
Huang
Jia-Hua
JH
Gu
Wei-Kang
WK
D002681:China; D018795:Device Approval; D007202:Indicators and Reagents / Q000145:classification / Q000592:standards; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000145:classification / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration
D007202:Indicators and Reagents; D011933:Reagent Kits, Diagnostic