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Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool

FDA UDI

by Fujirebio Diagnostics, Inc.

Identity

Trade Name
Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
Software FDA UDI
Model / Reference
CL0012 FDA UDI
Description
Software FDA UDI

Identifiers

Primary DI / UDI-DI
00869164000048 FDA UDI
510(k) Number
DEN200072 FDA UDI
GMDN Term
Laboratory instrument/analyser application software IVD FDA UDI

Classification

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laboratory instrument/analyser application software IVD

Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool by Fujirebio Diagnostics, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory instrument/analyser application software IVD.

Cleared under the same submission

DEN200072 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 3b0d7907-9eab-4688-ac05-0efb9c484391 35 fields · synced Jun 9, 2026