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Lumipulse G B-Amyloid 1-42-N Plasma Calibrator

FDA UDI

Class II (US FDA UDI)

by Fujirebio Inc.

Identity

Trade Name
Lumipulse G B-Amyloid 1-42-N Plasma Calibrator FDA UDI
Generic Name
Tau protein IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Lumipulse G B-Amyloid 1-42-N Plasma Calibrator FDA UDI
Model / Reference
235454 FDA UDI
Description
Lumipulse G B-Amyloid 1-42-N Plasma Calibrator FDA UDI

Identifiers

Primary DI / UDI-DI
04987270235454 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Amyloid B component IVD, kit, chemiluminescent immunoassayTau protein IVD, kit, chemiluminescent immunoassay

Lumipulse G B-Amyloid 1-42-N Plasma Calibrator by Fujirebio Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tau protein IVD, kit, chemiluminescent immunoassay.

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 Inc.

Sources (1)

  • FDA UDI da15577d-aa51-428a-9e50-3fc8d55cfabf 37 fields · synced Jun 1, 2026