Chemicon International, Inc. Meets CE Mark Deadline for Its Light Diagnostic Products.Business Editors/Health/Medical Writers TEMECULA, Calif.--(BUSINESS WIRE)--Dec. 8, 2003 Chemicon International, Inc., a division of Serologicals Corporation (NASDAQ/NM: SERO SERO Southeast Regional Office SERO Sekundaerrohstoffe (recycling, former GDR) SERO Syringe Exchange Resources Online SERO System Engineering/Engineer Release Order SERO Site Emergency Response Organisation (nuclear) ), announced today that, as required by IVDD IVDD In-Vitro Diagnostic Device (medical) IVDD Intervertebral Disc Disease directive of the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community , all qualifying Chemicon International, Inc. in vitro diagnostic (IVD (Interactive VideoDisc) See interactive video. ) products have been CE Marked for sales in Europe prior to the December 7, 2003 deadline. Chemicon International, Inc. obtained accreditation to ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 13485 in November of 2002 enabling the company to CE Mark IVD products according to IVDD directives. The IVD products manufactured by Chemicon International, Inc. are sold under the trade name of "Light Diagnostics(TM)." The ISO 13485 accreditation is a key requirement of European and other governmental regulatory authorities and the CE Mark allows Chemicon to market and distribute its IVD products in the European Union. ISO 13485 is the international standard for medical device manufacturers, built upon the conventional ISO 9000 system. The ISO 13485 standard complies with specific industry requirements relative to the United States Food and Drug Administration's current Good Manufacturing Practices and Quality System Regulations. Many countries worldwide rely on this standard as recognition of the highest quality control for regulation of medical devices. The successful completion of the ISO 13485 accreditation will increase the potential market for Chemicon's products worldwide, as it demonstrates the company's directive of providing consistent and reliable products. Chemicon International, headquartered in Temecula, California, USA, is a life science research and diagnostic products company engaged in developing, manufacturing and marketing products that provide innovative tools to accelerate biomedical research. Chemicon's products and services facilitate advancement in cell signaling, cancer, angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization. an·gi·o·gen·e·sis n. , apoptosis, developmental biology, cellular physiology, cell adhesion, neurobiology Neurobiology Study of the development and function of the nervous system, with emphasis on how nerve cells generate and control behavior. The major goal of neurobiology is to explain at the molecular level how nerve cells differentiate and develop their , and infectious disease. The company also has state-of-the art cGMP, TGA See TARGA. TGA - Targa Graphics Adaptor and ISO approved manufacturing facilities in the United States, Australia, and the United Kingdom. Chemicon supplies a broad selection of proven, top-quality, and consistent diagnostic test reagents for clinical and health organizations worldwide. About Serologicals and Chemicon Serologicals Corporation, headquartered in Atlanta, Georgia, is a global provider of biological products and enabling technologies, which are essential for the research, development and manufacturing of biologically based life science products. Customers include many of the leading research institutions and life science companies throughout the world. The Company's products and technologies are used in a wide variety of innovative applications within the areas of neurobiology, cell signaling, cancer, angiogenesis, apoptosis, developmental biology, cellular physiology, oncology, hematology, immunology, cardiology, infectious diseases, and molecular biology. Through its Chemicon Division, the Company also manufactures diagnostic products at its cGMP, ISO, and TGA approved facilities. Chemicon International, Inc., a wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. of Serologicals Corporation, is headquartered in Temecula, California. Serologicals has more than 800 employees worldwide, and its shares are traded on the NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on national stock market under the symbol SERO. For more information on Serologicals Corporation and Chemicon International, visit the companies' web sites at www.serologicals.com and www.chemicon.com. Serologicals is a registered trademark of Serologicals Royalty Company. |
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