cobas® Cdiff 07454945190

GUDID 00875197005677

Roche Molecular Systems, Inc.

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00875197005677
• NIH Device Record Key: 4b23b2a1-092c-4d98-abfb-21eb6b4a8553
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas® Cdiff
• Version Model Number: 07454945190
• Catalog Number: 07454945190
• 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: true
• Device Combination Product: false
• Single Use: true
• 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	00875197005677 [Primary]

FDA Product Code

• OOI: real time Nucleic acid amplification system

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: 2026-03-03
• Device Publish Date: 2026-02-23

Devices Manufactured by Roche Molecular Systems, Inc.

• 00875197005677 - cobas® Cdiff: 2026-03-03
• 00875197005677 - cobas® Cdiff: 2026-03-03
• 00875197005684 - cobas® Cdiff Control Kit: 2026-03-03
• 00875197007350 - cobas liat Bordetella panel nucleic acid test: 2026-03-03
• 00875197007367 - cobas liat Bordetella panel control kit: 2026-03-03
• 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