Home › Device types › SET
Immunoassay Blood Test For Amyloid Pathology Assessment
FDA product code SET · Class 2 · Immunology
8
Registered devices
0
Adverse events
7
Recalls
2
510(k) clearances
Devices with this code
Lumipulse G pTau 217 Plasma Immunoreaction Cartridges — Fujirebio EuropeElecsys Phospho-Tau (181P) Plasma — Roche Diagnostics GmbHLumipulse G B-Amyloid 1-42-N Plasma Calibrator — FUJIREBIO INC.Lumipulse B-Amyloid Plasma Controls — Fujirebio EuropeLumipulse pTau 217 Plasma Controls — Fujirebio EuropeLumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio — Fujirebio Diagnostics, Inc.Lumipulse G pTau 217 Plasma Calibrators — Fujirebio EuropeLumipulse G B-Amyloid 1-42-N Plasma — FUJIREBIO INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-11 | Fujirebio Diagnostics, Inc. | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity |
| 2025-12-11 | Fujirebio Diagnostics, Inc. | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity |
| 2025-12-11 | Fujirebio Diagnostics, Inc. | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity |
| 2025-12-11 | Fujirebio Diagnostics, Inc. | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity |
| 2025-12-11 | Fujirebio Diagnostics, Inc. | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity |
| 2025-12-11 | Fujirebio Diagnostics, Inc. | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity |
| 2025-12-11 | Fujirebio Diagnostics, Inc. | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.