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

Basic Information

• Brand Name: Lumipulse G B-Amyloid 1-42-N Plasma Calibrator
• Primary DI: 04987270235454
• Version / Model: 235454
• Company Name: FUJIREBIO INC.
• Labeler DUNS: 710873907
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-06
• Public Version: 4
• Public Version Date: 2025-06-19
• Public Version Status: Update
• Public Device Record Key: da15577d-aa51-428a-9e50-3fc8d55cfabf

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SET	Immunoassay Blood Test For Amyloid Pathology Assessment	Immunology	866.5840	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65218	Amyloid B component IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of amyloid B component, also known as amyloid beta or Aß, in a clinical specimen, using a chemiluminescent immunoassay method. It is used to aid the diagnosis of Alzheimer's disease.	No	Active
65902	Tau protein IVD, kit, chemiluminescent immunoassay	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987270235454	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K242706	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			4 Bottles per unit; 1.5mLs per bottle

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – -15 Degrees Celsius