Home GUDID 10742860100670 OSOM COVID-19 Test
Primary DI 10742860100670
Brand OSOM COVID-19 Test
Company SEKISUI DIAGNOSTICS, LLC
Model 1092
Catalog number 1092
Device description OSOM COVID-19 Test
Published 2026-01-19
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 00742860100673 Primary GS1 0 10742860100670 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 00742860100673 00742860100673 742860100673 0742860100673 10742860100670 10742860100670
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 966812344 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 00816862028416 WELLlife™ WONDFO USA CO., LTD. QVF 2026-06-01 00742860100673 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