title: [Studies on administration of in-vitro diagnostic reagents].
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.
authors: Shanghai Municipal Drug and Medical Device Evaluation Center.
authors: Ze
authors: Z
authors: Wang
authors: Hong
authors: H
authors: Qian
authors: Feng-Ling
authors: FL
authors: Xu
authors: Jia-Hua
authors: JH
authors: Huang
authors: Wei-Kang
authors: WK
authors: Gu
mesh_terms: 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
chemical_list: D007202:Indicators and Reagents; D011933:Reagent Kits, Diagnostic