FDA.reportPublic FDA data

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

Primary DI
00869164000048
Brand
Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool
Company
Fujirebio Diagnostics, Inc.
Model
CL0012
Device description
Software
Published
2022-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN200072000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN200072000Lumipulse G ß-Amyloid Ratio (1-42/1-40)Fujirebio Diagnostics,Inc.2022-05-04QSE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869164000048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869164000048008691640000488691640000480869164000048

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-544-3787customersupport_US@fujirebio-us.com

Regulatory Flags#

DUNS number
048524263
Device count
1
Kit
true
Lot or batch
true

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