← Back to catalogue
Lumipulse G pTau 217 Plasma Immunoreaction Cartridges
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Lumipulse G pTau 217 Plasma Immunoreaction Cartridges FDA UDI
- Generic Name
- Tau protein IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 3x14T, IVD-US FDA UDI
- Model / Reference
- 81550 FDA UDI
- Description
- Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 3x14T, IVD-US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05414470815500 FDA UDI
- 510(k) Number
- K242706 FDA UDI
- FDA Product Code
- SET FDA UDI
- GMDN Term
- Tau protein IVD, kit, chemiluminescent immunoassay 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, kit, chemiluminescent immunoassay
Lumipulse G pTau 217 Plasma Immunoreaction Cartridges by Fujirebio Europe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tau protein IVD, kit, chemiluminescent immunoassay.
- Lumipulse G B-Amyloid 1-42-N Plasma Calibrator — FUJIREBIO INC. · Class II
- Lumipulse G B-Amyloid 1-42-N Plasma — FUJIREBIO INC. · Class II
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 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fujirebio Europe
Sources (1)
- FDA UDI 0c79d7cd-5f30-4d7b-908b-4bd4aebeda46 37 fields · synced May 29, 2026