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Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

FDA UDI

Class II (US FDA UDI)

by Fujirebio Diagnostics, Inc.

Identity

Trade Name
Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio FDA UDI
Generic Name
Multiple Alzheimer's disease-associated marker IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio FDA UDI
Model / Reference
CL0073 FDA UDI
Description
Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio FDA UDI

Identifiers

Primary DI / UDI-DI
00869164000086 FDA UDI
510(k) Number
K242706 FDA UDI
FDA Product Code
SET FDA UDI
GMDN Term
Multiple Alzheimer's disease-associated marker 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

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple Alzheimer's disease-associated marker IVD, kit, chemiluminescent immunoassay

Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio by Fujirebio Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K242706 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fujirebio Diagnostics, Inc.

Sources (1)

  • FDA UDI c710bd2b-6ac2-41b1-98f0-a4507bc71a7e 35 fields · synced Jun 9, 2026