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Safety of laboratory analyzers for infection testing - results of the market surveillance by the BfArM until end 2007

The European Directive 98/79/EC on in vitro diagnostic medical devices (IVD) stipulates the marketing and post market surveillance of IVD in the European Economic Area. In cases of issues and field corrective actions, the manufacturers have to inform the responsible Competent Authorities (CA). In Ge...

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Detalles Bibliográficos
Autores principales:	Siekmeier, R, Halbauer, J, Mientus, W, Wetzel, D
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2009
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3521334/ https://www.ncbi.nlm.nih.gov/pubmed/20156760 http://dx.doi.org/10.1186/2047-783X-14-S4-216

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