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CE Marked Products for In Vitro Diagnostic (IVD) Use in the European Union:
CE Marked IVD MethoCult®
Features of CE Marked IVD Products:
- EC declaration of conformity and Certificate of Registration have been issued
- Universal symbols on labels and instructions for use, providing important product information without the need for language
- Detailed instructions for use included with CE Marked IVD products are now provided in English, French, German, Italian, and Spanish
- StemCell's CE Marking Policy Statement is available for more information
What is CE Marking? - CE Marking indicates that a product complies with safety, environmental, and quality standards in the European Union (EU).
- The CE Mark is a declaration of conformity with the provisions outlined in the Directive 98/79/EC of the European Parliament, and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices.
- The CE Mark verifies our exceptional product quality and ensures these products are eligible for sale in the EU.
Please click here to download a copy of the In Vitro Diagnostic Medical Devices Directive.
Alternative to Animal Testing:
In addition, MethoCult® media for human and mouse cells (H4001 and M3001, research use only formulations), have recently been validated by the European Centre for the Validation of Alternative Methods (ECVAM). ECVAM endorses the use of The Colony Forming Unit-Granulocyte/Macrophage (CFU-GM) Assay for Predicting Acute Neutropenia in Humans.
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