WELLlife™

Basic Information

• Brand Name: WELLlife™
• Primary DI: 00816862026924
• Version / Model: WCOVFLU-OTC-5
• Company Name: WONDFO USA CO., LTD.
• Labeler DUNS: 849098897
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2025-05-16
• Public Version: 1
• Public Version Date: 2025-05-26
• Public Version Status: New
• Public Device Record Key: c1eff99a-debd-4b18-8525-a6914485d569

Device Description

WELLlife™ COVID-19/Flu A&B Home Test Cassette, 5 Tests per Kitbox Copy

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Microbiology	866.3987	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66040	Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816862026921	GS1		72	In Commercial Distribution
Primary	00816862026924	GS1
Unit of Use	00816862026917	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 30 Degrees Celsius