Oct 03, 2016 Uncategorized Comments Off on Bioline is Certified to the ISO 13485 Quality Standard
CINCINNATI, Oct. 03, 2016 (GLOBE NEWSWIRE) — Bioline, The PCR Company, a wholly-owned subsidiary of Meridian Bioscience, Inc. (NASDAQ:VIVO) is proud to announce that the London R&D and Berlin manufacturing facilities are now fully accredited to the ISO 13485 quality standard.
Bioline recognizes the importance of adhering to a quality management system in the development, manufacture and supply of test components to the molecular diagnostic arena. We are committed to strengthening our relationships by meeting the quality standard our industrial partners need in their efforts to achieve test certification. Consequently, Bioline is delighted to announce that our production facilities in Berlin and research facilities in London are now certified to ISO 13485 quality standard. Our full range of industrial services includes custom assay development, bulk supply of test components, validation support, and private label OEM manufacture.
Marco Calzavara, President of Bioline, commented, “Our ISO 13485 certification means we offer complete confidence in Bioline as the supplier of molecular diagnostic test components. Our certification demonstrates our reproducibly high standards of quality, manufacturing consistency, material traceability and complete supply chain security. We look forward to expanding our contribution to the development of molecular diagnostic tests that improve animal and human health. Our own product development efforts are also guided by ISO 13485. We recently expanded our product portfolio to include a lyophilization-ready qPCR reagent, namely the SensiFAST™ Lyo-Ready No-ROX Mix, to assist our partners in the development of IVD tests.”
Richard L. Eberly, President, Chief Commercial Officer, stated, “Our ISO 13485 certification is an important milestone in the progression of Bioline. Our adherence to this quality standard builds on our understanding of our diagnostic partner’s requirements and demonstrates our commitment to being a trusted supplier in the development of new in vitro molecular diagnostic tests into the future. We look forward to strengthening our existing business and forging new relationships with diagnostic manufacturers for their bulk and custom needs within the framework of the ISO 13485 quality management system.”
About Meridian Bioscience, Inc.
Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. Utilizing a variety of methods, these products and diagnostic tests provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral and respiratory infections and blood lead levels. Meridian’s diagnostic products are used outside of the human body and require little or no special equipment. The Company’s products are designed to enhance patient well-being while reducing the total outcome costs of health care. Meridian has strong market positions in the areas of gastrointestinal and upper respiratory infections; serology, parasitology and fungal disease diagnosis, and blood lead level testing. In addition, Meridian is a supplier of rare reagents, specialty biologicals and related technologies used by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products and technologies to hospitals, reference laboratories, research centers, diagnostics manufacturers and biotech companies in more than 70 countries around the world. The Company’s shares are traded on the NASDAQ Global Select Market, symbol VIVO. Meridian’s website address is www.meridianbioscience.com.
FOR ADDITIONAL INFORMATION:
For more information about Bioline, please visit http://www.bioline.com.
CONTACT: Richard L. Eberly President, Chief Commercial Officer Meridian Bioscience, Inc. Phone: 513.271.3700 Rick.eberly@