Identity
- Trade Name
- Lumipulse B-Amyloid Plasma Controls FDA UDI
- Generic Name
- Amyloid B component IVD, control FDA UDI
- Device Name
- Lumipulse B-Amyloid Plasma Controls 2x2C, IVD-US FDA UDI
- Model / Reference
- 81559 FDA UDI
- Description
- Lumipulse B-Amyloid Plasma Controls 2x2C, IVD-US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05414470815593 FDA UDI
- 510(k) Number
- K242706 FDA UDI
- FDA Product Code
- SET FDA UDI
- GMDN Term
- Amyloid B component IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5840 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Amyloid B component IVD, control
Lumipulse B-Amyloid Plasma Controls by Fujirebio Europe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Amyloid B component IVD, control.
- AccuTrak — LGC Clinical Diagnostics, Inc. · Class I
- PreciControl beta-Amyloid (1-42) II — Roche Diagnostics Corp. · Class I
- Amyloid Beta Control Slides — BIO SB, INC. · Class I
- CalCheck beta-Amyloid (1-42) II — Roche Diagnostics Corp. · Class I
- Amyloid Beta control slides — BIO SB, INC. · Class I
- Lumipulse B-Amyloid Controls — FUJIREBIO INC.
Cleared under the same submission
K242706 also covers:
- Lumipulse G B-Amyloid 1-42-N Plasma — FUJIREBIO INC.
- Lumipulse G B-Amyloid 1-42-N Plasma Calibrator — FUJIREBIO INC.
- Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio — Fujirebio Diagnostics, Inc.
- Lumipulse G pTau 217 Plasma Calibrators — Fujirebio Europe
- Lumipulse G pTau 217 Plasma Immunoreaction Cartridges — Fujirebio Europe
- Lumipulse pTau 217 Plasma Controls — Fujirebio Europe
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fujirebio Europe
Sources (1)
- FDA UDI f0c4ddc4-b3c9-471e-a59c-57aab8304317 37 fields · synced May 30, 2026