Elecsys Phospho-Tau (181P) Plasma

Basic Information

• Brand Name: Elecsys Phospho-Tau (181P) Plasma
• Primary DI: 07613336216941
• Version / Model: 09697870190
• Catalog Number: 09697870190
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-22
• Public Version: 1
• Public Version Date: 2025-12-01
• Public Version Status: New
• Public Device Record Key: 4af8655e-c3f1-4f0e-932e-ff0e2b7a667e

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
53981	Tau protein IVD, kit, enzyme immunoassay (EIA)	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 an enzyme immunoassay (EIA) 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	07613336216941	GS1

Premarket Submissions

Submission Number	Supplement Number
K252163	000