Home GUDID 00816862028416 WELLlife™
Primary DI 00816862028416
Brand WELLlife™
Company WONDFO USA CO., LTD.
Model WCOVID-POC-25
Device description WELLlife™ COVID-19 Antigen Test Cassette, 25 Tests per Kitbox
Published 2026-06-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816862028416 Primary GS1 0 00816862028409 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816862028416 00816862028416 816862028416 0816862028416 00816862028409 00816862028409 816862028409 0816862028409
GMDN Terms# Term, Definition table Term Definition SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Regulatory Flags# DUNS number 849098897 Device count 25 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00742860100673 OSOM COVID-19 Test SEKISUI DIAGNOSTICS, LLC QVF 2026-01-19 10742860100670 OSOM COVID-19 Test SEKISUI DIAGNOSTICS, LLC QVF 2026-01-19 00382902560920 BD Veritor System for Rapid Detection of SARS-CoV-2 BECTON, DICKINSON AND COMPANY QVF 2025-08-21 30382902560921 BD Veritor System for Rapid Detection of SARS-CoV-2 BECTON, DICKINSON AND COMPANY QVF 2025-08-21 B379COVAF201 SCoV-2 Ag Detect™ Rapid Test INBIOS INTERNATIONAL, INC QVF 2024-09-13 B379COVAF501 SCoV-2 Ag Detect™ Rapid Test INBIOS INTERNATIONAL, INC QVF 2024-09-13 30014613339755 Sofia 2 QUIDEL CORPORATION QVF 2023-03-28