cobas® 4800 System Sample Preparation Kit 05235804190

GUDID 00875197003185

Roche Molecular Systems, Inc.

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

• Primary Device ID: 00875197003185
• NIH Device Record Key: 2a07b63a-4424-4f45-9832-baab3843b241
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas® 4800 System Sample Preparation Kit
• Version Model Number: 05235804190
• Catalog Number: 05235804190
• 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	00875197003185 [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: 2014-09-10

On-Brand Devices [cobas® 4800 System Sample Preparation Kit]

• 00875197003185: 05235804190
• 00875197003178: 05235782190