cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test 09048634190

GUDID 00875197006285

Roche Molecular Systems, Inc.

Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00875197006285
• NIH Device Record Key: 5554634b-0c10-4b0f-a48a-a20ab28861c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test
• Version Model Number: 09048634190
• Catalog Number: 09048634190
• 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: true
• 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	00875197006285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243400

FDA Product Code

• QOF: Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents

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: 2025-06-05
• Device Publish Date: 2025-05-28

Devices Manufactured by Roche Molecular Systems, Inc.

• 00875197006285 - cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test: 2025-06-05
• 00875197006285 - cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test: 2025-06-05
• 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
• 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