FDA device listing
Lumipulse G B-Amyloid 1-42-N Plasma Calibrators,Lumipulse G B-Amyloid 1-42-N Plasma IC,Lumipulse G pTau217/B-Amyloid…
FDA device listing 1470287116 · Fujirebio Diagnostics, Inc.
Key facts
| Proprietary names | Lumipulse G B-Amyloid 1-42-N Plasma Calibrators,Lumipulse G B-Amyloid 1-42-N Plasma IC,Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio,Lumipulse G pTau 217 Plasma Calibrators,Lumipulse G pTau 217 Plasma IC |
|---|---|
| Owner/operator | Fujirebio Diagnostics, Inc. |
| Owner/operator number | 10022860 |
| Premarket submissions | K242706 |
| Product codes | SET |
| Device names | SET - Immunoassay Blood Test For Amyloid Pathology Assessment |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.5840 |
| Review panels | Immunology |
| Registered establishments | Fujirebio Diagnostics, Inc., Fujirebio Europe N.V., Fujirebio Inc. |
| Establishment registrations | 2521625, 9615837, 3002895169 |
| FEI numbers | 2521625, 3002608770, 3002895169 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database