Elecsys Anti-HBe 11820613160

GUDID 04015630938865

Roche Diagnostics GmbH

Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 04015630938865
• NIH Device Record Key: b2b079b6-d4c4-45fa-a9ea-f2072f1b9f40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Anti-HBe
• Version Model Number: 11820613160
• Catalog Number: 11820613160
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630938865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P190005

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: 2021-04-15
• Device Publish Date: 2021-04-07

On-Brand Devices [Elecsys Anti-HBe]

• 04015630938865: 11820613160
• 04015630940134: Anti-HBe Elecsys E2G 300