FDA.reportPublic FDA data

Lumipulse G pTau 217 Plasma Immunoreaction Cartridges

Primary DI
05414470815500
Brand
Lumipulse G pTau 217 Plasma Immunoreaction Cartridges
Company
Fujirebio Europe
Model
81550
Device description
Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 3x14T, IVD-US
Published
2025-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
05414470815500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414470815500054144708155005414470815500

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+32093291329info@fujirebio.com

Regulatory Flags#

DUNS number
297346645
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414470156870LiRAS for LiPA HCV v1156872025-05-30
05414470816590INNO-LiPA HCV 2.0 Genotyping816592025-05-30
05414470816606INNO-LiPA HCV 2.0 Amp816602025-05-30
05414470816613INNO-LiPA HCV 2.0 Control816612025-05-30
05414470816620INNO-LiPA HCV 2.0 Genotyping816622025-05-30
05414470816637INNO-LiPA HCV 2.0 Amp816632025-05-30
05414470815579Lumipulse G pTau 217 Plasma Calibrators815572025-06-16
05414470815586Lumipulse pTau 217 Plasma Controls815582025-06-16
05414470815593Lumipulse B-Amyloid Plasma Controls815592025-06-16
05414470804214TENDIGO Disposable TraysCat No. 804212022-09-14
05414470806287Auto-LiPA 48 806282020-02-24
05414470806294Auto-LIA 48806292020-02-24
05414470804122TENDIGO804122020-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336216941Elecsys Phospho-Tau (181P) PlasmaRoche Diagnostics GmbHSET2025-11-22
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
00869164000086Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Fujirebio Diagnostics, Inc.SET2024-11-04