Data / Medical devices / Japan / Fujirebio Inc.
Fujirebio Inc.: FDA-registered device maker in Sagamihara-shi Kanagawa, Japan, 5 510(k) clearances
Fujirebio Inc. is registered with the FDA (registration 3002895169) in Sagamihara-shi Kanagawa, Japan. It lists 11 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 16, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002895169
- Address
- 1-3-14 Tanashioda, Chuo-ku, Sagamihara-shi Kanagawa, Japan, 252-0245
- Owner or operator
- Fujirebio Diagnostics, Inc. (10022860)
- Roles
- Manufacturer
- First device listed
- April 19, 2016
- Registered through
- 2026
- Brand names listed
- ADVIA Centaur XPT Cytokeratin Fragment 21-1 MCM (CYFRA MCM) - Siemens, ADVIA Centaur XPT Tumor Marker Quality Controls (TMQC) - Siemens, ARCHITECT CYFRA 21-1 Controls, ARCHITECT CYFRA 21-1 Controls (China), ARCHITECT CYFRA 21-1 Controls (ROW), ARCHITECT Methotrexate Extended Range Controls (China), ARCHITECT Methotrexate Extended Range Controls (ROW), ARCHITECT Thyroglobulin Controls and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| AlzheimerS Disease Pathology Assessment Test | QSE | 2 | Manufacturer | accessdata.fda.gov |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Manufacturer | accessdata.fda.gov |
| Antigen, Inflammatory Response Marker, Sepsis | NTM | 2 | Manufacturer | accessdata.fda.gov |
| Calibrator, Secondary | JIT | 2 | Manufacturer | accessdata.fda.gov |
| Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens | PMT | 2 | Manufacturer | accessdata.fda.gov |
| Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | LIP | 2 | Manufacturer | accessdata.fda.gov |
| Immunoassay Blood Test For Amyloid Pathology Assessment | SET | 2 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls Unassayed | OHQ | 1 | Manufacturer | accessdata.fda.gov |
| Procalcitonin Assay | PRI | 2 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | LTK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 16, 2025 | K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | SET | Substantially Equivalent | Fujirebio Diagnostics,Inc. | accessdata.fda.gov |
| May 4, 2022 | DEN200072 | Lumipulse G ß-Amyloid Ratio (1-42/1-40) | QSE | Unknown | Fujirebio Diagnostics,Inc. | accessdata.fda.gov |
| December 10, 2017 | K172713 | Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set | PRI | Substantially Equivalent | Fujirebio Diagnostics,Inc. | accessdata.fda.gov |
| July 5, 2016 | K153145 | Lumipulse G TP-N Immunoreaction Cartridge Set | LIP | Substantially Equivalent | Fujirebio Diagnostics,Inc. | accessdata.fda.gov |
| May 21, 2015 | K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators | LTK | Substantially Equivalent | Fujirebio Diagnostics,Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Immunoassay Blood Test For Amyloid Pathology Assessment
- All makers of Procalcitonin Assay
- All makers of Antigen, Inflammatory Response Marker, Sepsis
- All makers of Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
- All makers of Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
- All makers of Multi-Analyte Controls Unassayed
Updated May 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.