Elecsys HBsAg II 08814864160

GUDID 07613336198278

Roche Diagnostics GmbH

Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336198278
• NIH Device Record Key: 1fcd69fa-c62d-49c3-a08c-ea10baa307e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys HBsAg II
• Version Model Number: 08814864160
• Catalog Number: 08814864160
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336198278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160019

FDA Product Code

• LOM: Test, hepatitis b (b core, be antigen, be antibody, b core igm)

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: 2020-04-03
• Device Publish Date: 2020-03-26

On-Brand Devices [Elecsys HBsAg II]

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