therascreen® KRAS RGQ PCR Kit

Basic Information

• Brand Name: therascreen® KRAS RGQ PCR Kit
• Primary DI: 04053228002048
• Version / Model: 1
• Catalog Number: 870021
• Company Name: QIAGEN GmbH
• Labeler DUNS: 317103745
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-04
• Public Version: 3
• Public Version Date: 2020-05-06
• Public Version Status: Update
• Public Device Record Key: 0183de6f-edfd-418d-8380-66845fdbd810

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	04053228002048	GS1