FDA.reportPublic FDA data

Lumipulse pTau 217 Plasma Controls

Primary DI
05414470815586
Brand
Lumipulse pTau 217 Plasma Controls
Company
Fujirebio Europe
Model
81558
Device description
Lumipulse pTau 217 Plasma Controls 2x2C, 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
05414470815586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414470815586054144708155865414470815586

GMDN Terms#

Term, Definition table
TermDefinition
Tau protein IVD, controlA material which is used to verify the performance of an assay 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.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-15 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
05414470815500Lumipulse G pTau 217 Plasma Immunoreaction Cartridges815502025-06-16
05414470815579Lumipulse G pTau 217 Plasma Calibrators815572025-06-16
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
05414470815500Lumipulse G pTau 217 Plasma Immunoreaction CartridgesFujirebio EuropeSET2025-06-16
05414470815579Lumipulse G pTau 217 Plasma CalibratorsFujirebio 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