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Study on Clinical Application and Supervision of LC-MS in in Vitro Diagnosis Test / 中国医疗器械杂志
Article em Zh | WPRIM | ID: wpr-1010263
Biblioteca responsável: WPRO
ABSTRACT
From the perspective of technical evaluation, this study reviewed the current situation of application and clinical application of medical device products were detected by liquid chromatography-tandem mass spectrometry in the market in recent years. The regulatory requirements of these products in China, USA, EU and Japan were compared and analyzed, and the monitoring situation of adverse events after listing, the standards for reference and the domestic and foreign regulatory documents were combined, the clinical application and regulatory risks of the product were analyzed. The problems such as pre-treatment, system matching, adequacy of performance index requirements, inter-room consistency, reference interval and registration unit were discussed and suggestions for supervision were given, with a view to the field of product R&D and production, review and approval of supervision to provide technical reference.
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Texto completo: 1 Base de dados: WPRIM Assunto principal: Padrões de Referência / Cromatografia Líquida / Espectrometria de Massas em Tandem / Japão País/Região como assunto: Asia Idioma: Zh Revista: Chinese Journal of Medical Instrumentation Ano de publicação: 2023 Tipo de documento: Article
Texto completo: 1 Base de dados: WPRIM Assunto principal: Padrões de Referência / Cromatografia Líquida / Espectrometria de Massas em Tandem / Japão País/Região como assunto: Asia Idioma: Zh Revista: Chinese Journal of Medical Instrumentation Ano de publicação: 2023 Tipo de documento: Article