Panels › Immunology › Product code SET · Class 2
Immunoassay Blood Test For Amyloid Pathology Assessment
Regulation 866.5840
2510(k)s in 12 months (4 all time)
7recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in SET
| Company | 510(k)s | Recalls |
|---|---|---|
| Fujirebio Diagnostics,Inc. | 1 | 7 |
| Roche Diagnostics | 2 | 0 |
| C2N Diagnostics, LLC | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. Product Name: Lumipulse -Amyloid Plasma Controls
Model/Catalog Number: 81559
Software Version: Not Applicable
Product Description: Lumipulse -Amyloid Plasma Controls:
This quality control product can Open, Classified |
SET | K242706 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. Product Name: Lumipulse G -Amyloid 1-42-N Plasma Calibrators
Model/Catalog Number: 235454
Software Version: Not Applicable
Product Description: Lumipulse G -Amyloid 1-42-N Plasma Calibrators:
The -Amy Open, Classified |
SET | K242706 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. Product Name: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges
Model/Catalog Number: 235447
Software Version: Not Applicable
Product Description: Lumipulse G -Amyloid 1-42-N Plasma Immunor Open, Classified |
SET | K242706 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. Product Name: Lumipulse pTau 217 Plasma Controls
Model/Catalog Number: 81558
Software Version: Not Applicable
Product Description: Lumipulse pTau 217 Plasma Controls:
This quality control product can Open, Classified |
SET | K242706 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. Product Name: Lumipulse G pTau 217 Plasma Calibrators
Model/Catalog Number: 81557
Software Version: Not Applicable
Product Description: Lumipulse G pTau 217 Plasma Calibrators:
The pTau 217 plasma con Open, Classified |
SET | K242706 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges
Model/Catalog Number: 81550
Software Version: Not Applicable
Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartrid Open, Classified |
SET | K242706 |
| Feb 5, 2026 | Fujirebio Diagnostics, Inc. Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Model/Catalog Number: CL0073
Software Version: Not Applicable
Product Description: Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio is an in Open, Classified |
SET | K242706 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.