cobas® prime User Workflow Reagent Bottle 08460426190

GUDID 00875197006247

Roche Molecular Systems, Inc.

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• Primary Device ID: 00875197006247
• NIH Device Record Key: 5e449376-fa6e-4260-8fd6-bc9571ed16b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas® prime User Workflow Reagent Bottle
• Version Model Number: 08460426190
• Catalog Number: 08460426190
• Company DUNS: 071674100
• Company Name: Roche Molecular Systems, Inc.
• 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	00875197006247 [Primary]

FDA Product Code

• JQW: STATION, PIPETTING AND DILUTING, 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: 2020-07-09
• Device Publish Date: 2020-07-01

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