cobas¿ 4800 CTNG Test 05235944190

GUDID 00875197003314

Roche Molecular Systems, Inc.

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• Primary Device ID: 00875197003314
• NIH Device Record Key: b164108d-933b-4520-a906-357d63282b20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas¿ 4800 CTNG Test
• Version Model Number: 1.0
• Catalog Number: 05235944190
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00875197003314 [Primary]

FDA Product Code

• LSL: DNA-REAGENTS, NEISSERIA

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: 2016-03-31

On-Brand Devices [cobas¿ 4800 CTNG Test]

• 00875197003314: 1.0
• 00875197003307: 1.0