title: [Discussion on Current Registration Situation and Problems of in Vitro Diagnostic Device of Tumor Marker].
abstract: This paper aims to analysis of the general problem in the registration dossier and make recommendations on in vitro diagnostic device of tumor markers. On the basis of introducing declarations of the reagents, analysis registration dossier common problems occurs in the products intend to detect novel tumor markers and the combined detection product for multiple tumor markers, and analysis the special requirements for such products.
authors.forename: Zhaozhao
authors.initials: Z
authors.lastname: Han
mesh_terms: D014408:Biomarkers, Tumor / Q000032:analysis*; D006801:Humans; D009369:Neoplasms / Q000175:diagnosis*; D011933:Reagent Kits, Diagnostic / Q000592:standards*
chemical_list: D014408:Biomarkers, Tumor; D011933:Reagent Kits, Diagnostic