cobas Buffer Negative Control Kit 09051953190

GUDID 00875197006926

Roche Diagnostics GmbH

PCR/NAT negative control IVD

• Primary Device ID: 00875197006926
• NIH Device Record Key: 4869f3e5-0323-4e9a-9d82-67da2509b773
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas Buffer Negative Control Kit
• Version Model Number: 09051953190
• Catalog Number: 09051953190
• 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: 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	00875197006926 [Primary]

FDA Product Code

• NSU: Instrumentation for clinical multiplex test systems

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: 2024-06-13
• Device Publish Date: 2024-06-05

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• 07613336227794 - Reference electrode: 2025-03-13
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