Sigma-Aldrich Announces CE Mark Certification
Sigma-Aldrich Corporation is pleased to announce the certification of its Cell Culture and hematology & histology products with a CE Mark, making them eligible for sale in the European Union.
Under the European IVD Directive, certain products must meet regulatory requirements in order to qualify for sale and distribution in the European Union. The CE Marking indicates that a product complies with EU safety, environmental, and quality standards. Sigma-Aldrich has satisfactorily completed the testing and registration required to obtain CE Marking for approximately 400 of its products in the Cell Culture and Hematology & Histology product lines.
Eight product families in the Hematology & Histology line, including 250 products, have received the CE Marking, including Routine and Special Hematology stains, Routine and Special Histology stains, Histopaque Cell Separation media, Cytochemical stains, Cytology stains, and Histology stains.
The Cell Culture line received CE marking for 17 product families that include 150 products. Product families given CE Markings were Liquid Media with or without glutamine and sodium pyruvate, Concentrated Liquid Media, Salt Solutions with and without sodium bicarbonate, trypsin and penicillin solutions, Powered Media with and without glutamine, Powdered Salt Mixtures, Amniocyte Media, Bone Marrow Media, BSK-H Media, Fetal Bovine Serum, Cytogenics reagents and Supplements, L15 Leibovitz Media and Peripheral Blood Medica.
"Sigma-Aldrich's commitment to quality and safety are second to none," said Marilyn Baltz, PhD, Regulatory Site Manager at Sigma-Aldrich. "Obtaining the CE Mark confirms the excellence of our products and secures our presence in the European Union marketplace."
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