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.



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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.


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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, ISO 9001, EN46001 and ISO 14001*.  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.

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Fujirebio Europe and the ISO 14001 standard

At Fujirebio Europe N.V. we have always given great value to the environment. This environmental awareness is embedded throughout our organization and has been valued by implementing an Environmental Management System (EMS). Since November 25, 2013 our company has been officially certified for our EMS which fulfils the requirements of the international standard ISO 14001:2015. The Scope, Policy, Objectives and Certificate are listed below.


Development, manufacturing and related administrative services of in vitro diagnostic and research kits and instruments.

Policy & Aim

It is Fujirebio Europe's environmental policy to develop and produce diagnostic products with environmental care and respect for a safe and healthy workplace. Our corporate values of Inspiration, Result Orientation, Teamwork and Care are woven in every facet of our commitment to manage environmental aspects as an integral part of our business. So Together we foster Inspiration and turn it into sustainable Solutions which express Care for the environment.

It is our aim to comply with applicable legal and other requirements and to reduce the impact of our operations by preventing and controlling pollution and by reducing the use of hazardous raw materials. Fujirebio Europe engages to continually improve in environmental performance.


Fujirebio Europe has the intention to keep on maintaining an Environmental Management System compliant to ISO 14001 and engages to reduce:

  1. Paper use (cfr. digitalization).
  2. Energy consumption (cfr. replacement of some large energy consuming installations, refurbishment cleanrooms 2nd floor, optimize HVAC conditions, …).
  3. CO2 emission during transport (cfr. promote sustainable mobility for employees, electrical company cars, …).
  4. The use of hazardous materials (cfr. IVD kits & instruments, R&D projects, …)


Download a copy of our ISO 14001:2015 Certificate here: