Lumipulse G pTau 217 Plasma Immunoreaction Cartridges

Basic Information

• Brand Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges
• Primary DI: 05414470815500
• Version / Model: 81550
• Company Name: Fujirebio Europe
• Labeler DUNS: 297346645
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-16
• Public Version: 1
• Public Version Date: 2025-06-24
• Public Version Status: New
• Public Device Record Key: 0c79d7cd-5f30-4d7b-908b-4bd4aebeda46

Device Description

Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 3x14T, IVD-US

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
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	05414470815500	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			42 Tests per kit

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius