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Fujirebio Diagnostics,Inc. FDA Approvals
0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| ADVIA Centaur Cytokeratin Fragment 21-1510(k)Dec 16, 2025Immunology |
| Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio510(k)May 16, 2025Immunology |
| Lumipulse G ß-Amyloid Ratio (1-42/1-40)510(k)May 4, 2022Immunology |