Lumipulse pTau 217 Plasma Controls

Basic Information

• Brand Name: Lumipulse pTau 217 Plasma Controls
• Primary DI: 05414470815586
• Version / Model: 81558
• 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: 7737f746-6c25-470d-b6df-cc89785ac198

Device Description

Lumipulse pTau 217 Plasma Controls 2x2C, 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
53983	Tau protein IVD, control	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05414470815586	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; 1.5 mL per bottle

Storage Conditions

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