Elecsys HBsAg II Auto Confirm 08741034162

GUDID 07613336183137

Roche Diagnostics GmbH

Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336183137
• NIH Device Record Key: b9ef0cc0-ece2-41d8-9bf1-46b84d460588
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys HBsAg II Auto Confirm
• Version Model Number: 08741034162
• Catalog Number: 08741034162
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 1
• 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	07613336183137 [Primary]

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 Auto Confirm]

• 07613336172902: 08741034190
• 07613336183137: 08741034162