Elecsys Anti-HBc IgM 07026811160

GUDID 07613336153932

Roche Diagnostics GmbH

Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336153932
• NIH Device Record Key: a13acf05-517f-4e42-be4d-e60418297d05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Anti-HBc IgM
• Version Model Number: 07026811160
• Catalog Number: 07026811160
• 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	07613336153932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110022

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-19

On-Brand Devices [Elecsys Anti-HBc IgM]

• 04015630911615: 11820567160
• 07613336153932: 07026811160