Elecsys Total -Tau CSF

Basic Information

• Brand Name: Elecsys Total -Tau CSF
• Primary DI: 07613336221761
• Version / Model: 08846634160
• Catalog Number: 08846634160
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-23
• Public Version: 2
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: d17353e3-7555-4d45-982d-53cf48e08902

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
QSE	Alzheimer’s disease pathology assessment test	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	07613336221761	GS1

Premarket Submissions

Submission Number	Supplement Number
K231348	000