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

Basic Information

• Brand Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
• Primary DI: 00869164000086
• Version / Model: CL0073
• Company Name: Fujirebio Diagnostics, Inc.
• Labeler DUNS: 048524263
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-04
• Public Version: 5
• Public Version Date: 2025-09-23
• Public Version Status: Update
• Public Device Record Key: c710bd2b-6ac2-41b1-98f0-a4507bc71a7e

Device Description

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

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
67591	Multiple Alzheimer's disease-associated marker IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple markers associated with Alzheimer's disease [e.g., tau protein (t-tau or p-tau), amyloid B] in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used to detect amyloid pathology to aid in the diagnosis of Alzheimer's disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00869164000086	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K242706	000