Bioclone Australia Pty. Limited is an Australian-based subsidiary of Hitachi Chemical Co., Ltd., specialising in the design and manufacture of high quality immunodiagnostic products for medical and research laboratory markets globally. Associated contract services are also provided by Bioclone. Bioclone was formed in 1981 to take advantage of Australian expertise in medical research and biotechnology. A collaborative project with the CSIRO and the Garvan Institute for Medical Research gave Bioclone an excellent range of monoclonal antibodies to pituitary hormones from which diagnostic kits were later developed. In 1996, Bioclone was acquired by Hitachi Chemical Co., Ltd., however, the company continues to trade under the Bioclone name as it has done since its inception. In 1997, Bioclone moved to a new purpose-built facility with expanded capacity for production, contract manufacturing and contract research and development. Bioclone now produces Australia’s largest range of immunoassay products for the medical diagnostics market. The products are marketed through a network of distributors internationally and directly, generally on a standing-order basis, domestically. The company has maintained a reputation for high quality products and services with close customer contact being key to the understanding of market requirements for immunodiagnostic tests. Bioclone achieved and has maintained quality-related certifications since its early days. Currently Bioclone’s quality management system is fully certified to ISO 9001 (current edition), ISO 13485 (current edition), GMP and the CE Mark; and Bioclone has US FDA clearance with 510(k) approval to market for ten ELISA products in the range. Bioclone continues to invest in innovation and new product development both through collaboration with research organisations and its own Research and Development team. Additionally, the company is constantly seeking new strategic alliances to augment established relationships made, over more than 25 years in the biotech industry.
我们专注于为医学和科研试验室市场提供高质量的免疫诊断产品，成立于1981年，利用澳大利亚在医学研究和生物科技上的专业水平，与CSIRO和 Garvan科研所的合作使我们具有开发垂体激素单克隆抗体的能力，现在Bioclone成为澳大利亚医学诊断市场上最大的免疫化验产品的制造商。我们有10种ELISA检测包通过了FDA认证。 |
