cobas® KRAS Mutation Test

Basic Information

• Brand Name: cobas® KRAS Mutation Test
• Primary DI: 00875197004199
• Version / Model: 1.0
• Catalog Number: 05852170190
• Company Name: Roche Molecular Systems, Inc.
• Labeler DUNS: 071674100
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-30
• Public Version: 3
• Public Version Date: 2021-02-03
• Public Version Status: Update
• Public Device Record Key: 3e9a0f7d-067f-47b6-a151-cd072351d04b

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
58280	KRAS gene mutation IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative detection of the KRAS (v-ki-ras2 kirsten rat sarcoma viral oncogene homolog) mutation status and/or to evaluate a clinical specimen to predict or monitor the response to treatment with epidermal growth factor receptor (EGFR) inhibitors by determining the KRAS mutation status of tumour tissue using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00875197004199	GS1