Elecsys Anti-HBc II

Basic Information

• Brand Name: Elecsys Anti-HBc II
• Primary DI: 07613336183106
• Version / Model: 09014926162
• Catalog Number: 09014926162
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2025-02-19
• Public Version: 1
• Public Version Date: 2025-02-27
• Public Version Status: New
• Public Device Record Key: b214d8ea-328f-4946-a6d1-d027e11a4796

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
QHM	Serology tests used for infectious disease screening of blood and plasma donations	Microbiology	610.40	U

GMDN Terms

Code	Name	Definition	Implantable	Status
48295	Hepatitis B virus core antigen IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus core antigen in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	07613336228487	GS1
Primary	07613336183106	GS1