cobas® EGFR Mutation Test v2

Basic Information

• Brand Name: cobas® EGFR Mutation Test v2
• Primary DI: 00875197005448
• Version / Model: 2.0
• Catalog Number: 07248563190
• Company Name: Roche Molecular Systems, Inc.
• Labeler DUNS: 071674100
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-16
• Public Version: 3
• Public Version Date: 2021-02-03
• Public Version Status: Update
• Public Device Record Key: 1e75681f-a708-46c8-8db0-4c374ee2d1e0

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OWD	Somatic gene mutation detection system	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
58271	Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to predict or monitor the response to treatment with epidermal growth factor receptor (EGFR) inhibitors by determining the EGFR mutation status or mRNA expression of the EGFR gene, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00875197005448	GS1