FDA.reportPublic FDA data

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

Primary DI
00869164000086
Brand
Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Company
Fujirebio Diagnostics, Inc.
Model
CL0073
Device description
Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Published
2024-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
SETImmunoassay Blood Test For Amyloid Pathology Assessment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SETImmunoassay Blood Test For Amyloid Pathology AssessmentImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242706000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242706000Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioFujirebio Diagnostics,Inc.2025-05-16SET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869164000086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869164000086008691640000868691640000860869164000086

GMDN Terms#

Term, Definition table
TermDefinition
Tau protein IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of microtubule-associated tau protein [total tau (t-tau) or phosphorylated tau (p-tau)] in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used to aid the diagnosis of neurodegenerative disorders such as Alzheimer's disease.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
610-240-3800customersupport.us@fujirebio-us.com

Regulatory Flags#

DUNS number
048524263
Device count
1
Kit
true

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00869164000079Emit Cyclosporine Sample40080862023-12-06
00869164000000MESOMARK801-9052014-09-17
00869164000048Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator ToolCL00122022-11-10
00850212007096Lumipulse G Wash Solution40082482017-10-06
00869164000017Lumipulse G ROMACL00042016-09-19
00869164000024ROMA404-10US2016-09-19
00850212007072Fertility Control 21301622020-12-07
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00850212007003FITC Anti-Rabies Monoclonal Globulin800-0922016-09-16
00850212007010Serodia TP-PA16262016-09-16
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00850212007034Vitamin D Control21301522016-09-16
00850212007065Syphilis Control21301702017-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336216941Elecsys Phospho-Tau (181P) PlasmaRoche Diagnostics GmbHSET2025-11-22
05414470815500Lumipulse G pTau 217 Plasma Immunoreaction CartridgesFujirebio EuropeSET2025-06-16
05414470815579Lumipulse G pTau 217 Plasma CalibratorsFujirebio EuropeSET2025-06-16
05414470815586Lumipulse pTau 217 Plasma ControlsFujirebio EuropeSET2025-06-16
05414470815593Lumipulse B-Amyloid Plasma ControlsFujirebio EuropeSET2025-06-16
04987270235447Lumipulse G B-Amyloid 1-42-N PlasmaFUJIREBIO INC.SET2025-01-06
04987270235454Lumipulse G B-Amyloid 1-42-N Plasma CalibratorFUJIREBIO INC.SET2025-01-06