Identity
- Trade Name
- Lumipulse B-Amyloid Controls FDA UDI
- Generic Name
- Amyloid B component IVD, control FDA UDI
- Model / Reference
- 234907 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987270234907 FDA UDI
- 510(k) Number
- DEN200072 FDA UDI
- GMDN Term
- Amyloid B component IVD, control FDA UDI
Classification
- 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 Controls by Fujirebio Inc. — 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 Plasma Controls — Fujirebio Europe · Class II
Cleared under the same submission
DEN200072 also covers:
- Lumipulse G B-Amyloid 1-40 Calibrator Set — FUJIREBIO INC.
- Lumipulse G B-Amyloid 1-40 Immunoreaction Cartridges — FUJIREBIO INC.
- Lumipulse G B-Amyloid 1-42 Calibrator Set — FUJIREBIO INC.
- Lumipulse G B-Amyloid 1-42 Immunoreaction Cartridges — FUJIREBIO INC.
- Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool — Fujirebio Diagnostics, Inc.
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fujirebio Inc.
Sources (1)
- FDA UDI 6444506d-236d-4532-9835-51f06a812e82 36 fields · synced May 30, 2026