cobas¿ EGFR Mutation Test v2 07248563190

GUDID 00875197005448

Roche Molecular Systems, Inc.

Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00875197005448
• NIH Device Record Key: 1e75681f-a708-46c8-8db0-4c374ee2d1e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas¿ EGFR Mutation Test v2
• Version Model Number: 2.0
• Catalog Number: 07248563190
• 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	00875197005448 [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: 2015-12-16

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