cobas¿ PCR Urine Sample Kit 05170486190

GUDID 00875197002898

Roche Molecular Systems, Inc.

Sexually transmitted infection (STI) testing specimen collection kit IVD, point-of-care

• Primary Device ID: 00875197002898
• NIH Device Record Key: fc936d82-e227-4012-80bf-f969a54037b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas¿ PCR Urine Sample Kit
• Version Model Number: 1.0
• Catalog Number: 05170486190
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00875197002898 [Primary]

FDA Product Code

• LSL: DNA-REAGENTS, NEISSERIA

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-08-09
• Device Publish Date: 2016-03-31

Devices Manufactured by Roche Molecular Systems, Inc.

• 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