A Heritage of Innovation
Fujirebio started in Japan in 1950. It developed the first TPHA diagnostics kit, the gold standard for syphilis testing, in 1966. Since then, we have built a strong tradition of innovating, developing, manufacturing and marketing high-quality in vitro diagnostics testing solutions worldwide. Over the years, the acquisition of Centocor Diagnostics, CanAg Diagnostics and Innogenetics have further bolstered our capabilities and expertise in various clinical areas. Today, working closely with one of the world’s top commercial laboratories (SRL, Inc.), another entity within the H.U. Group, Fujrebio combines expertise and experience for the diagnostics market that is more potent than ever.
Related links:
Pioneers of Ground-breaking IVD Solutions
Key milestones in our journey include the development of the world’s first fully automated chemiluminescent enzyme immunoassay (CLEIA) instrument – better known as Lumipulse® – which is used around the world today. Our product lines span the range from specialized manual and automated testing to fully automated routine testing solutions. In addition, we provide gold standard assays in the fields of neurodegeneration, infectious disease, and oncology, continuing to offer both novel and routine biomarkers for a variety of other diseases including infection with SARS-CoV-2.
Related links:
Flexible and Reliable Business Partner
Our R&D teams and production teams located in Japan, Sweden, Belgium and the US are committed to develop and manufacture products with the highest quality. This has earned us a strong reputation among our customers and global partners at leading diagnostic companies. The Fujirebio group of companies is certified as compliant with ISO 13485:2016, ISO 9001:2015, EN46001 and ISO 14001:2015*. Above all, the insights and know-how that our global team bring to each stage of development of a new biomarker or system keep our customers and partners at the forefront of early diagnostics and state-of-the-art healthcare solutions.
* Please visit our Quality section for the status of compliant certifications of each company.
Related links:
Environmental Health and Safety Policy
Fujirebio Diagnostics, Inc. management and employees are committed to protecting the environment, and the health and safety of all people working for or on behalf of our organization. Our Environmental Health and Safety Management System (EHSMS), provides the framework for developing objectives in support of continual improvement.
We maintain the effectiveness of our EHSMS by our commitment to:
-
Compliance – We are committed to complying with all applicable requirements.
-
Communication – We are committed to communicating the requirements of our EHSMS to all who are working for or on behalf of the organization.
-
Continual Improvement – We are committed to continually improving our environmental health and safety performance through developing objectives that are in line with our significant environmental aspects.
-
Prevention of Pollution – We are committed to preventing pollution through eliminating and/or reducing pollution at its source, and by promoting energy savings and recycling throughout the organization.
Employee participation is key to Fujirebio Diagnostics’ success as a safe workplace and as an effective steward of the environment.
Download Our ISO 14001:2015 Certificate
Fujirebio Diagnostics Inc. is an AdvaMed Certified Company
