Home GUDID 00816862027303 WELLlife™
Primary DI 00816862027303
Brand WELLlife™
Company WONDFO USA CO., LTD.
Model WCOV-CON-5
Device description WELLlife™ COVID-19 Antigen Test Control Kit, 5 Positive Control Swabs and 5 Negative Control Swabs 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 false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name MJZ Kit, Direct Antigen, Positive Control
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MJZ Kit, Direct Antigen, Positive Control Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816862027303 Primary GS1 0 00816862027297 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 00816862027303 00816862027303 816862027303 0816862027303 00816862027297 00816862027297 816862027297 0816862027297
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 849098897 Device count 5 DM exempt false Premarket exempt true 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 30014613340768 QuickVue™ WONDFO USA CO., LTD. MJZ 2025-10-31 08809115900401 QuickFinder™ COVID-19/Flu Antigen Pro Control Swab Kit OSANG HEALTHCARE Co., Ltd. MJZ 2025-03-12 15099590745172 ACCESS HIV Ag/Ab combo QC Beckman Coulter, Inc. MJZ 2024-03-15 10845357043754 Helix Elite™ Molecular Standards: Inactivated Standard MICROBIOLOGICS INC. MJZ 2022-02-16 10811877010712 BinaxNOW® Malaria Positive Control Kit Alere Scarborough, Inc. MJZ 2016-09-03