Abstract
To offer the guidance of the registration application of in vitro diagnostic (IVD) reagents,the technical requirements for registration of the pathogen-specific Immunoglobulin M (IgM) qualitative test reagents were discussed.The application paperwork including the evaluation of analytical performance was analyzed based on the the legal requirement from the China Food and Drug Administration (CFDA) and the experience of the IVD registration.(Chin J Lab Med,2013,36:947-949) Key words: Immunoglobulin M; Reagent kits; diagnostic; Indicators and reagents; Registries; Evaluation studies
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