cobas pro B-Gate update Kit 08763640001

GUDID 07613336164846

Roche Diagnostics GmbH

Ion-selective analyser IVD, automated Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD

• Primary Device ID: 07613336164846
• NIH Device Record Key: 2d566cec-401d-4f2d-bf81-2e876749fe45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas pro B-Gate update Kit
• Version Model Number: 08763640001
• Catalog Number: 08763640001
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	07613336164846 [Primary]

FDA Product Code

• JQP: Calculator/data processing module, for clinical use

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: 2020-03-30
• Device Publish Date: 2020-03-20

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