FDA.reportPublic FDA data

Lumipulse G B-Amyloid 1-42-N Plasma Calibrator

Primary DI
04987270235454
Brand
Lumipulse G B-Amyloid 1-42-N Plasma Calibrator
Company
FUJIREBIO INC.
Model
235454
Device description
Lumipulse G B-Amyloid 1-42-N Plasma Calibrator
Published
2025-01-06
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
04987270235454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987270235454049872702354544987270235454

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 Temperature-25 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
710873907
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
04987270235058Lumipulse G BRAHMS PCT Immunoreaction Cartridges2350582018-04-02
04987270235584Lumipulse Infectious Diseases Controls2355842025-07-31
04987270230466Lumipulse G Dilution Cartridges2304662019-12-27
04987270234440Soda Lime for LUMIPULSE System2344402020-01-10
04987270235447Lumipulse G B-Amyloid 1-42-N Plasma2354472025-01-06
04987270235485Lumipulse G B-Amyloid Controls (Plasma)-N2354852025-01-06
04987270226964Beckman Coulter PK TP System226964PH30002016-09-16
04987270234938Lumipulse G BRAHMS PCT Calibrator Set2349382018-04-02
04987270234945Lumipulse BRAHMS PCT Controls2349452018-04-02
04987270234884Lumipulse G B-Amyloid 1-42 Calibrator Set2348842022-10-31
04987270234891Lumipulse G B-Amyloid 1-40 Calibrator Set2348912022-10-31
04987270234907Lumipulse B-Amyloid Controls2349072022-10-31
04987270231432Lumipulse G B-Amyloid 1-42 Immunoreaction Cartridges2314322022-11-10
04987270231753Lumipulse G B-Amyloid 1-40 Immunoreaction Cartridges2317532022-11-10
04987270231869Lumipulse G SARS-CoV-2 Ag Calibrator Set2318692023-02-01
04987270231876Lumipulse SARS-CoV-2 Ag Controls2318762023-02-01
04987270260340Lumipulse G SARS-CoV-2 Ag Immunoreaction Cartridges2603402023-02-01
04987270234259LUMIPULSE G12002342592019-12-27
04987270230190Lumipulse G whole PTH Immunoreaction Cartridges2301902019-12-18
04987270230206Lumipulse G Whole PTH Calibrators2302062019-12-18

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
00869164000086Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Fujirebio Diagnostics, Inc.SET2024-11-04