QuickVue™

Basic Information

• Brand Name: QuickVue™
• Primary DI: 30014613340768
• Version / Model: 20519
• Catalog Number: 20519
• Company Name: WONDFO USA CO., LTD.
• Labeler DUNS: 849098897
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-31
• Public Version: 1
• Public Version Date: 2025-11-10
• Public Version Status: New
• Public Device Record Key: f5254e51-152f-4225-a804-076bf9cdfed3

Device Description

QuickVue™ Influenza+SARS Test Control Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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
MJZ	Kit, Direct Antigen, Positive Control	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48247	Multiple-genus respiratory virus antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from multiple virus genera associated with respiratory diseases in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30014613340768	GS1
Package	50014613340762	GS1		24	In Commercial Distribution

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius