Under the European IVD Directive, certain products must meet regulatory requirements in order to qualify for sale and distribution in the European Union
Sigma-Aldrich reports the certification of its cell culture and haematology and histology products with a CE mark, making them eligible for sale in the European Union.
The CE marking indicates that a product complies with EU safety, environmental, and quality standards.
Sigma-Aldrich says ity has satisfactorily completed the testing and registration required to obtain CE marking for approximately 400 of its products in the cell culture and haematology and histology product lines.
Eight product families in the haematology and histology line, including 250 products, have received the CE marking, including routine and special haematology 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 media. "Sigma-Aldrich's commitment to quality and safety is second to none," said Marilyn Baltz, regulatory site manager.
"Obtaining the CE Mark confirms the excellence of our products and secures our presence in the European Union marketplace."
