cobas® HIV-1/HIV-2 Qualitative 09040528190

GUDID 00875197006384

Roche Molecular Systems, Inc.

HIV1/HIV2 nucleic acid IVD, control

• Primary Device ID: 00875197006384
• NIH Device Record Key: 336175f6-3489-4e91-98d7-bc7303cfb926
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas® HIV-1/HIV-2 Qualitative
• Version Model Number: 09040528190
• Catalog Number: 09040528190
• 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: 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

• Special Storage Condition, Specify: Between 0 and 0 *NA
• Special Storage Condition, Specify: Between 0 and 0 *NA
• Special Storage Condition, Specify: Between 0 and 0 *NA
• Special Storage Condition, Specify: Between 0 and 0 *NA
• Special Storage Condition, Specify: Between 0 and 0 *NA
• Special Storage Condition, Specify: Between 0 and 0 *NA
• Special Storage Condition, Specify: Between 0 and 0 *NA
• Special Storage Condition, Specify: Between 0 and 0 *NA
• Special Storage Condition, Specify: Between 0 and 0 *NA
• Special Storage Condition, Specify: Between 0 and 0 *NA
• Special Storage Condition, Specify: Between 0 and 0 *NA
• Special Storage Condition, Specify: Between 0 and 0 *NA
• Special Storage Condition, Specify: Between 0 and 0 *NA

Device Identifiers

Device Issuing Agency	Device ID
GS1	00875197006384 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP190360

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: 2025-04-08
• Device Publish Date: 2025-03-31

Devices Manufactured by Roche Molecular Systems, Inc.

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• 00875197006292 - cobas liat SARS-CoV-2 v2 nucleic acid test: 2025-06-05
• 00875197007299 - cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test: 2025-06-05
• 00875197007305 - cobas liat SARS-CoV-2, Influenza A/B & RSV control kit: 2025-06-05
• 00875197006384 - cobas® HIV-1/HIV-2 Qualitative: 2025-04-08
• 00875197006384 - cobas® HIV-1/HIV-2 Qualitative: 2025-04-08
• 07613336180112 - AVENIO Edge System: 2025-04-02
• 07613336155790 - AcfS L and D Equipment Installation Bundle: 2025-02-07
• 07613336172353 - AcfS Library Robot: 2025-02-07