Elecsys HBsAg Confirmatory Test 11820648122

GUDID 04015630911110

Roche Diagnostics GmbH

Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 04015630911110
• NIH Device Record Key: 4e8121bf-6568-47ce-bd0e-45c4a493a86f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys HBsAg Confirmatory Test
• Version Model Number: 11820648122
• Catalog Number: 11820648122
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630911110 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-30
• Device Publish Date: 2014-09-10

On-Brand Devices [Elecsys HBsAg Confirmatory Test]

• 04015630911110: 11820648122
• 07613336175293: HBsAg Confirmatory Test Elecsys cobas e V2