Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of H.U. Group HoldingsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Fujirebio Diagnostics with 45 510(k) clearances and 7 device recalls. The most recent is a 510(k) clearance dated Dec 16, 2025: ADVIA Centaur Cytokeratin Fragment 21-1.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 16, 2025 | ADVIA Centaur Cytokeratin Fragment 21-1K250925 · OVK | 510(k) clearances |
| Dec 11, 2025 | Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: LumipuClass II · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate | Device recalls |
| Dec 11, 2025 | Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: LClass II · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate | Device recalls |
| Dec 11, 2025 | Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product DescrClass II · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate | Device recalls |
| Dec 11, 2025 | Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: LumipClass II · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate | Device recalls |
| Dec 11, 2025 | Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Class II · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate | Device recalls |
| Dec 11, 2025 | Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product DescrClass II · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate | Device recalls |
| Dec 11, 2025 | Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Class II · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate | Device recalls |
| May 16, 2025 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioK242706 · SET | 510(k) clearances |
| May 4, 2022 | Lumipulse G ß-Amyloid Ratio (1-42/1-40)DEN200072 · QSE | 510(k) clearances |
| Sep 4, 2020 | Lumipulse G CA15-3K192524 · MOI | 510(k) clearances |
| Aug 24, 2020 | ST AIA-PACK BNPK192380 · NBC | 510(k) clearances |
| May 14, 2020 | Lumipulse G CA19-9-NK200997 · NIG | 510(k) clearances |
| Oct 22, 2019 | Lumpipulse G CA19-9-NK191973 · NIG | 510(k) clearances |
| Aug 30, 2019 | Lumipulse G whole PTHK190702 · CEW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
