Elecsys HBsAg II 08814848162

GUDID 07613336228456

Roche Diagnostics GmbH

Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336228456
• NIH Device Record Key: 432ec56d-4cea-4a72-b8df-d82305b0e87e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys HBsAg II
• Version Model Number: 08814848162
• Catalog Number: 08814848162
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 20
• 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	07613336183076 [Primary]
GS1	07613336228456 [Unit of Use]

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: 2024-11-15
• Device Publish Date: 2024-11-07

On-Brand Devices [Elecsys HBsAg II]

• 07613336106396: 07914482160
• 07613336198285: 08814856160
• 07613336198278: 08814864160
• 07613336168103: 08814848190
• 04015630940028: 07251076190
• 04015630939008: 04687787160
• 07613336228456: 08814848162