Elecsys HBsAg Confirmatory Test 09127127190

GUDID 07613336175293

HBsAg Confirmatory Test Elecsys cobas e V2

Roche Diagnostics GmbH

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

• Primary Device ID: 07613336175293
• NIH Device Record Key: b3c32945-669c-4fa3-b42a-9fd1253f6f5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys HBsAg Confirmatory Test
• Version Model Number: 09127127190
• Catalog Number: 09127127190
• 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	07613336175293 [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: 2022-02-03
• Device Publish Date: 2022-01-26

On-Brand Devices [Elecsys HBsAg Confirmatory Test]

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