Elecsys HIV Duo 08836973160

GUDID 07613336215845

Elecsys HIV Duo

Roche Diagnostics GmbH

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• Primary Device ID: 07613336215845
• NIH Device Record Key: f90acc16-f1ca-4d49-b3b5-c64b503cdf78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys HIV Duo
• Version Model Number: 08836973160
• Catalog Number: 08836973160
• 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: true
• 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	07613336215845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP190403

FDA Product Code

• MZF: Test, HIV detection

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: 2022-09-30
• Device Publish Date: 2022-09-22

On-Brand Devices [Elecsys HIV Duo]

• 07613336166949: 08836973190
• 07613336215845: Elecsys HIV Duo