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CE mark and IVD symbols
In accordance with the guideline 98/79/EC by the European Parliament for In-Vitro-Diagnostics (IVD guideline), Sanquin has obtained the CE mark for its in-vitro-diagnostic products. The CE mark guarantees the highest level of safety for patients, users and third parties. For the CE mark on blood grouping reagents, Sanquin co-operated with the Dutch Notified Body KEMA Quality B.V. (identification number 0344) and acquired CE certification.The IgG subclass reagents and most CD monoclonal antibodies (used for diagnostic purposes) have been extensively documented and meet the requirements of the IVDD. The Technical Documentation includes detailed product descriptions, stability data, validations and descriptions of the quality management system. For most products the package inserts are available in English, German, French, Italian, Spanish, Portuguese, Greek, Swedish and Danish (except CD monoclonal antibodies; not in Greek, Swedish and Danish). More information
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