Lumipulse G pTau 217 Plasma Calibrators

FDA UDI

Class II (US FDA UDI)

by Fujirebio Europe

Identity

Trade Name: Lumipulse G pTau 217 Plasma Calibrators FDA UDI
Generic Name: Tau protein IVD, calibrator FDA UDI
Device Name: Lumipulse G pTau 217 Plasma Calibrators 1x5C, IVD-US FDA UDI
Model / Reference: 81557 FDA UDI
Description: Lumipulse G pTau 217 Plasma Calibrators 1x5C, IVD-US FDA UDI

Identifiers

Primary DI / UDI-DI: 05414470815579 FDA UDI
510(k) Number: K242706 FDA UDI
FDA Product Code: SET FDA UDI
GMDN Term: Tau protein IVD, calibrator 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Tau protein IVD, calibrator

Lumipulse G pTau 217 Plasma Calibrators by Fujirebio Europe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tau protein IVD, calibrator.

CalSet Phospho-Tau (181P) — Roche Diagnostics Corp. · Class II
CalSet Total-Tau — Roche Diagnostics Corp. · Class II

Cleared under the same submission

K242706 also covers:

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 604f8fba-a0c5-4e9b-bdd7-4a3055309f6b 37 fields · synced Jun 1, 2026