Data / Medical devices / Japan / Fujirebio Inc. Ube Facility
Fujirebio Inc. Ube Facility: FDA-registered device maker in Yamaguchi, Japan, 2 510(k) clearances
Fujirebio Inc. Ube Facility is registered with the FDA (registration 3014643041) in Yamaguchi, Japan. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 21, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014643041
- Address
- Aza-Ushiake, Oaza-Yoshiwa Ube-shi, Yamaguchi, Japan, 759-0134
- Owner or operator
- Fujirebio Diagnostics, Inc. (10022860)
- Roles
- Manufacturer
- First device listed
- October 17, 2007
- Registered through
- 2026
- Brand names listed
- Lumipulse G CA125II Calibrators, Lumipulse G CA125II IC, Lumipulse G Dilution Cartridges, Lumipulse G Wash Solution 231173, Lumipulse G Wash Solution 4008248, Lumipulse G1200 Instrument, PK CMV-PA System, Serodia TP-PA and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Manufacturer | accessdata.fda.gov |
| Antigens, Ha, Treponema Pallidum | GMT | 2 | Manufacturer | accessdata.fda.gov |
| Calibrator, Secondary | JIT | 2 | Manufacturer | accessdata.fda.gov |
| System, Test, Automated Blood Grouping And Antibody | KSZ | 2 | Manufacturer | accessdata.fda.gov |
| Test, Donor, Cmv | MZE | 2 | 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 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 |
| November 13, 1997 | K971502 | SERODIA TP-PA | GMT | Substantially Equivalent | Scimedx Tekfile Services | accessdata.fda.gov |
Compare with other makers
- All makers of Antigens, Ha, Treponema Pallidum
- All makers of Test, Donor, Cmv
- All makers of System, Test, Automated Blood Grouping And Antibody
- All makers of Calibrator, Secondary
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- All makers of Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Updated May 21, 2015. 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.