Diagnostic Equipment
Fujirebio Diagnostics, Inc
201 Great Valley Pkwy, Malvern, PA 19355, United States
- Manufacturer
- CE MARKING, FDA-CLEARED
About Fujirebio Diagnostics, Inc
Fujirebio Diagnostics, Inc. is headquartered in Malvern, Pennsylvania, and operates as a wholly owned subsidiary of Japan’s H.U. Group Holdings Inc. The company’s founding year and original founders are not disclosed in public materials. The company develops and manufactures in vitro diagnostic (IVD) products, including the fully automated Lumipulse® platform, assay kits for neurodegenerative and other conditions, instruments, software, controls, and raw materials. It also operates as a contract development and manufacturing organization (CDMO), offering partners end-to-end services from biomarker research through clinical validation, regulatory submission, and commercial production. Specific facility size, headcount, and annual volumes are not published. Its product portfolio spans neurology (Alzheimer’s, multiple sclerosis, Parkinson’s, ALS), oncology, infectious disease, autoimmune disorders, cardiac markers, diabetes, fertility, and transplantation. Recent collaborations include a letter of intent with Alzinova for a blood-based Alzheimer’s test and a sales partnership with Sysmex for dementia testing. Regulatory clearances include FDA-cleared biomarkers for blood-based Alzheimer’s diagnosis, CE marking for pTau 217 and NfL assays, Health Canada Class II licenses, and ANVISA authorization in Brazil. Fujirebio emphasizes an open partnership model, providing diagnostic raw materials, reagents, and full development-to-manufacturing services to other technology providers. The company states that revenues from these partnerships are reinvested into R&D to fuel its innovation engine, aiming to multiply breakthroughs across diagnostic platforms and reach more patients than it could alone.
Manufacturing capabilities
Core processes
Inspection & quality
Assembly & services
Industries served
- In vitro diagnostics
- Neurology
- Oncology
- Infectious diseases
- Autoimmune diseases
- Cardiac diagnostics
- Diabetes
- Fertility
- Genetic disorders
- Transplantation
- Bone metabolism
- Hypertension
- Inflammation
- Interstitial pneumonia
Materials
Diagnostic raw materials · Reagents · Controls · Calibrators
Equipment
- Lumipulse® platform
- Lumipulse G NfL Blood assay
- Lumipulse G pTau 217 Plasma assay
- Lumipulse G pTau 217 CSF assay
Company details
- Location
- Malvern, Pennsylvania
- Company type
- Manufacturer
- Certifications
- CE MARKING, FDA-CLEARED
Frequently asked questions
Where is Fujirebio Diagnostics, Inc located?
Fujirebio Diagnostics, Inc is located at 201 Great Valley Pkwy, Malvern, PA 19355, United States.
What does Fujirebio Diagnostics, Inc do?
Fujirebio Diagnostics, Inc is listed under Diagnostic Equipment, and its listed capabilities and products include IVD biomarker research and innovation, Contract development and manufacturing (CDMO), Diagnostic raw material and reagent supply, Full development, manufacturing, clinical and regulatory services, Fully automated immunoassay testing (Lumipulse platform) and Manual and semi-automated assay kits.
What industries does Fujirebio Diagnostics, Inc serve?
Fujirebio Diagnostics, Inc lists In vitro diagnostics, Neurology, Oncology, Infectious diseases and Autoimmune diseases among the industries it serves.
What certifications does Fujirebio Diagnostics, Inc have?
Certifications on file for Fujirebio Diagnostics, Inc: CE MARKING and FDA-CLEARED.
How do I request a quote from Fujirebio Diagnostics, Inc?
Use the Request a quote button on this page to send Fujirebio Diagnostics, Inc your requirements through FirmsLedger, or call (610) 240-3800 and visit fujirebio.com.
What companies are similar to Fujirebio Diagnostics, Inc?
Other Diagnostic Equipment companies in Pennsylvania listed on FirmsLedger include JFD-PK Medical LLC, Actuated Medical, Inc. and B & G Medical.