Elecsys Anti-HBc II 09014926162

GUDID 07613336228487

Roche Diagnostics GmbH

Hepatitis B virus core antigen IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336228487
• NIH Device Record Key: b214d8ea-328f-4946-a6d1-d027e11a4796
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Anti-HBc II
• Version Model Number: 09014926162
• Catalog Number: 09014926162
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336183106 [Primary]
GS1	07613336228487 [Unit of Use]

FDA Product Code

• QHM: Serology tests used for infectious disease screening of blood and plasma donations

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-27
• Device Publish Date: 2025-02-19

On-Brand Devices [Elecsys Anti-HBc II]

• 07613336153925: 07026790160
• 07613336142295: 07374160160
• 07613336228487: 09014926162