Home GUDID 00742860100673 OSOM COVID-19 Test
Primary DI 00742860100673
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
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 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 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