Identity
- Trade Name
- Lumipulse pTau 217 Plasma Controls FDA UDI
- Generic Name
- Tau protein IVD, control FDA UDI
- Device Name
- Lumipulse pTau 217 Plasma Controls 2x2C, IVD-US FDA UDI
- Model / Reference
- 81558 FDA UDI
- Description
- Lumipulse pTau 217 Plasma Controls 2x2C, IVD-US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05414470815586 FDA UDI
- 510(k) Number
- K242706 FDA UDI
- FDA Product Code
- SET FDA UDI
- GMDN Term
- Tau protein 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: Tau protein IVD, control
Lumipulse pTau 217 Plasma Controls by Fujirebio Europe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tau protein IVD, control.
- VALIDATE — LGC Clinical Diagnostics, Inc. · Class I
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- Tau control slides — BIO SB, INC. · Class I
- VALIDATE — LGC Clinical Diagnostics, Inc. · Class I
- PreciControl Total-Tau — Roche Diagnostics Corp. · Class I
- VALIDATE — LGC Clinical Diagnostics, Inc. · Class I
- pTau Phospho/Thr 181 Control Slides — BIO SB, INC. · Class I
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 B-Amyloid Plasma Controls — Fujirebio Europe
- Lumipulse G pTau 217 Plasma Calibrators — Fujirebio Europe
- Lumipulse G pTau 217 Plasma Immunoreaction Cartridges — 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 7737f746-6c25-470d-b6df-cc89785ac198 37 fields · synced May 30, 2026