cobas® HIV-1 09040803190

GUDID 00875197006407

Roche Molecular Systems, Inc.

HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00875197006407
• NIH Device Record Key: e8146f1d-3377-4a50-ba5c-607a54749d89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas® HIV-1
• Version Model Number: 09040803190
• Catalog Number: 09040803190
• Company DUNS: 071674100
• Company Name: Roche Molecular Systems, Inc.
• 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: false
• 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	00875197006407 [Primary]

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: 2021-12-22
• Device Publish Date: 2021-12-10

Devices Manufactured by Roche Molecular Systems, Inc.

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• 04015630936557 - DOCKING STATION SHORT: 2022-09-16
• 00875197006445 - cobas® NHP Negative Control Kit: 2022-08-09
• 04015630929009 - cobas x 480 Analyzer: 2022-06-10
• 00875197006391 - cobas® HCV: 2021-12-22
• 00875197006407 - cobas® HIV-1: 2021-12-22
• 00875197006407 - cobas® HIV-1: 2021-12-22