Elecsys Anti-HCV II 08837058162

GUDID 07613336228432

Roche Diagnostics GmbH

Hepatitis C virus total antibody IVD, kit, chemiluminescent assay

• Primary Device ID: 07613336228432
• NIH Device Record Key: 2db29ee6-9746-47da-a61d-b2c3dc0c25ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Anti-HCV II
• Version Model Number: 08837058162
• Catalog Number: 08837058162
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 16
• 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	07613336183052 [Primary]
GS1	07613336228432 [Unit of Use]

FDA Product Code

• QHM: Serology tests used for infectious disease screening of blood and plasma donations

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: 2025-02-26
• Device Publish Date: 2025-02-18

On-Brand Devices [Elecsys Anti-HCV II]

• 04015630936670: Anti-HCV II 200-Test Kit
• 04015630936663: Anti-HCV II 100-Test Kit
• 07613336228432: 08837058162