WELLlife™

Basic Information

• Brand Name: WELLlife™
• Primary DI: 00816862024609
• Version / Model: WV01P0003
• Company Name: WONDFO USA CO., LTD.
• Labeler DUNS: 849098897
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2024-12-20
• Public Version: 1
• Public Version Date: 2024-12-30
• Public Version Status: New
• Public Device Record Key: 560e6bea-ec3a-450e-a391-1a8f69059661

Device Description

WELLlife™ COVID-19/Influenza A&B Test Control Kit, 5 Positive Control Swabs and 5 Negative Control Swabs per Kitbox

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
QKP	Coronavirus Antigen Detection Test System.	Unknown		N
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64922	SARS-CoV-2 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 severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816862024606	GS1		24	In Commercial Distribution
Primary	00816862024609	GS1
Unit of Use	00816862024616	GS1

Customer Contacts

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

Storage Conditions

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