cobas¿ KRAS Mutation Test 05852170190

GUDID 00875197004199

Roche Molecular Systems, Inc.

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• Primary Device ID: 00875197004199
• NIH Device Record Key: 3e9a0f7d-067f-47b6-a151-cd072351d04b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas¿ KRAS Mutation Test
• Version Model Number: 1.0
• Catalog Number: 05852170190
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00875197004199 [Primary]

FDA Product Code

• OWD: Somatic gene mutation detection system

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: 2015-07-30

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