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Sign in to claim this brandFujirebio Diagnostics, Inc.
US
Last updated September 17, 2026
About
Fujirebio is an R&D-driven company constantly developing new technologies and unique biomarkers with high clinical value. Our group mission is to create new value in healthcare and thereby contribute to human health and the future of medical care.
From the manufacturer's own website. Source
Information
- Country
- US
- Address
- 201 Great Valley Parkway, Malvern, PA, 19355
- Website
- fdi.com
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2521625
- DUNS Number
- —
Catalogue (63)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cyfra 21-1 Eia Model 211-10 | K100831 | FDA 510(k) | Class II | Active |
| Lumipulse G FSH-N Calibrators | K163534 | FDA 510(k) | Class II | Active |
| Olympus Pk(tm) Tp | K893124 | FDA 510(k) | Class II | Active |
| Fujirebio Diagnostics Ca 19-9 Ria | K020566 | FDA 510(k) | Class II | Active |
| Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators | K151378 | FDA 510(k) | Class II | Active |
| Architect Sirolimus Assay | K070822 | FDA 510(k) | Class II | Active |
| Lumipulse G E2-III Calibrators | K163053 | FDA 510(k) | Class II | Active |
| Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set | K172713 | FDA 510(k) | Class II | Active |
| Lumipulse G TSH-III Immunoreaction Cartridges | K171103 | FDA 510(k) | Class II | Active |
| Architect Ca 125 Ii Assay | K042731 | FDA 510(k) | Class II | Active |
| Fujirebio Diagnostics Tumor Marker Control Model 108-20 | K101809 | FDA 510(k) | Class I | Active |
| Ab-Trol And Private Label Glucose Control Solution | K080273 | FDA 510(k) | Class I | Active |
| Fdi Glucose Control Solutions | K102260 | FDA 510(k) | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (8)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 11, 2025 | Z-1305-2026 | — | open, classified | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). |
| Dec 11, 2025 | Z-1301-2026 | — | open, classified | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). |
| Dec 11, 2025 | Z-1304-2026 | — | open, classified | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). |
| Dec 11, 2025 | Z-1303-2026 | — | open, classified | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). |
| Dec 11, 2025 | Z-1302-2026 | — | open, classified | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). |
| Dec 11, 2025 | Z-1306-2026 | — | open, classified | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). |
| Dec 11, 2025 | Z-1307-2026 | — | open, classified | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). |
| Jul 29, 2010 | Z-1606-2011 | — | terminated | presence of material attached to the bottom of some wells in places visible to the naked eye, which caused an overestimation of the sample. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Fujirebio Diagnostics AB Molndal Vastra Gotaland · SE FEI 3027273565