cobas® 4800 System Wash Buffer Kit 05235871190

GUDID 00875197003246

Roche Molecular Systems, Inc.

Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00875197003246
• NIH Device Record Key: e811d942-460c-459f-9996-1013da10aace
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas® 4800 System Wash Buffer Kit
• Version Model Number: 05235871190
• Catalog Number: 05235871190
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00875197003246 [Primary]

FDA Product Code

• MAQ: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-11

On-Brand Devices [cobas® 4800 System Wash Buffer Kit]

• 00875197003246: 05235871190
• 00875197003239: 05235863190