cobas HPV for use on the cobas 6800/8800 systems 07460155190

GUDID 00875197005752

Roche Molecular Systems, Inc.

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• Primary Device ID: 00875197005752
• NIH Device Record Key: 23dc1012-cebb-4705-9b6b-f6300d91c129
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas HPV for use on the cobas 6800/8800 systems
• Version Model Number: 07460155190
• Catalog Number: 07460155190
• 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: true
• 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	00875197005752 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-14
• Device Publish Date: 2021-06-04

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