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CE Certificate
for the In-vitro-Diagnostic
The CE marking shows that the product complies with the requirements according to EU regulation 765/2008. With this marking the manufacturer indicates that the product is in conformity with the applicable requirements which are set out in Community harmonization legislation.
Further legal features apply to medical products since these must not only be safe but also medically and technically effective within the framework of the purpose defined by the manufacturer.
The CE marking demonstrates that all requirements are met in a conformity assessment procedure. In particular, the aspects of safety are important, such as the analysis of risks and side effects, reduction of infection risks, completeness of the use instructions.
ELISA Kits offers many high-quality products with a CE marking, which are especially well suited for in vitro diagnostics (IVD) as well as for food and allergy analysis. Our broad spectrum of in vitro diagnostic products includes ELISAs for the detection of a wide range of pathogens (e.g. viruses, bacteria, fungi), quantitative determinations of hormones as well as the detection of different metabolic products and foreign substances in body fluids (saliva, plasma, serum, etc.)
Quelle: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0809:FIN:EN:PDF
Diagnostic relevant products:
Use the filter on the right or the search box below to find your product.
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Product Code: ILE-DNA01 -
Product Code: ILE-GLI02
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Product Code: ILE-GLI01
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Product Code: ILE-GLI03
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Product Code: ILE-RHF02
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Product Code: ILE-RHF01
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Product Code: ILE-RHF03
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Product Code: ILE-SCG26
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Product Code: ILE-SCG25
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Product Code: ILE-SCG80
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Product Code: ILE-SCG210
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Product Code: ILE-SCG06
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Product Code: ILE-TGG01
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Product Code: ILE-TPG01
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Product Code: ILE-IGE02
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