Fujirebio Diagnostics, Inc.


Fujirebio is a pioneer in the diagnostics industry, focused on developing new technologies and biomarkers with high clinical value. Founded in Japan in 1950, it has a strong tradition of innovating, manufacturing, and marketing high-quality in vitro diagnostics solutions worldwide. The company has expanded its capabilities through acquisitions and collaborates closely with top laboratories to enhance its market offerings. It operates globally with offices in Belgium, France, China, Germany, Italy, Japan, Spain, Sweden, and the United States, among others. The company offers a wide range of products including diagnostic kits, antibodies, genotyping kits, and biomarkers, and provides contract manufacturing and development services.

Industries

health-care
medical
medical-device
wellness

Nr. of Employees

Very Large (1000+)

Fujirebio Diagnostics, Inc.

Gent, Oost-Vlaanderen, Belgium, Europe


Products

Automated immunoassay analyzers (mid-sized)

Mid-sized fully automated immunoassay analyzers designed for clinical laboratory throughput and integration with automated assay kits.

Fully automated immunoassay kits

Assay kits developed for use on automated immunoassay analyzers for quantitative measurement of biomarkers in blood and CSF.

Manual and semi-automated assay kits

Manual and semi-automated formats including line-probe and immunoblot kits for molecular and serological testing.

Controls, calibrators and reagent raw materials

Manufactured controls and calibrators plus antibodies, antigens and other raw reagents for assay production, validation and routine quality control.

Preprogrammed automated test procedures

Instrument protocols for standardized execution of assays on compatible analyzers to reduce operator configuration and improve reproducibility.

Laboratory software for result interpretation and data management

Software tools for reading, interpreting and managing assay data generated by laboratory analyzers, with compatibility for laboratory workflows.

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Services

OEM / Contract manufacturing for IVD controls and reagents

Contract production and packaging of controls, calibrators, matrix-selected materials and reagents at small and large scale.

Assay automation and instrument protocol provisioning

Distribution of preprogrammed automated test procedures and laboratory software for standardized execution and interpretation of assays on supported analyzers.

Regulatory documentation and quality support

Provision of product regulatory artifacts and support materials to assist with compliance and submissions.

Customer technical support and training

Technical support channels, training materials and troubleshooting resources for product operation and maintenance.

Regional commercial and technical office support

Local subsidiaries and regional offices providing commercial, regulatory and technical interfaces across Europe, Asia and North America.

Expertise Areas

  • In-vitro diagnostics (IVD) development
  • Immunoassay design and automation
  • Biomarker discovery and clinical validation
  • Neurodegenerative biomarker assays (CSF and blood)
  • Show More (6)

Key Technologies

  • Automated immunoassay analyzers
  • Chemiluminescent enzyme immunoassay
  • Single-molecule counting and ultrasensitive detection
  • Line-probe genotyping assays
  • Show More (4)

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