Discussion on Current Registration Situation and Problems of in Vitro Diagnostic Device of Tumor Marker.
- Author:
Zhaozhao HAN
- Publication Type:Journal Article
- MeSH:
Biomarkers, Tumor;
analysis;
Humans;
Neoplasms;
diagnosis;
Reagent Kits, Diagnostic;
standards
- From:
Chinese Journal of Medical Instrumentation
2015;39(5):361-362
- CountryChina
- Language:Chinese
-
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.
