cobas¿ HBV Quantitative nucleic acid test for use on the cobas¿ 68008800 System 07000979190

GUDID 00875197004885

Roche Diagnostics GmbH

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• Primary Device ID: 00875197004885
• NIH Device Record Key: 98efb26a-312b-41e7-8a82-3266ee79cd1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas¿ HBV Quantitative nucleic acid test for use on the cobas¿ 68008800 System
• Version Model Number: 7000979190
• Catalog Number: 07000979190
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00875197004885 [Primary]

FDA Product Code

• MKT: Hepatitis Viral B DNA Detection

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: 2015-12-04

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