FDA.reportPublic FDA data

SARS-CoV-2 antigen IVD, control

Definition
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.
GUDID devices
10
Last updated
2026-08-18 06:11:11

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00895160002991Nano-Check™ COVID-19 Antigen Control KitNANO-DITECH CORPORATIONMD-8147EX2026-08-07
00816862024609WELLlife™ WONDFO USA CO., LTD.WV01P00032024-12-20
B502BSB9374CS0SARS-CoV-2 Control SlidesBIO SB, INC.BSB-9374-CS2025-03-18
10816862024606WELLlife™ WONDFO USA CO., LTD.WV01P00032024-12-20
04987270231876Lumipulse SARS-CoV-2 Ag ControlsFUJIREBIO INC.2318762023-02-01
10845357043754Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.HE0068AG2022-02-16
B085K086M60Audit MicroControls Control FD COVID-19 Antigen – NucleocapsidAALTO SCIENTIFICK086M-62022-02-04
10758750033560VITROSORTHO-CLINICAL DIAGNOSTICS, INC.61999432021-03-22
10811877011306BinaxNOW COVID-19 Ag Positive Control Swab Pack Alere Scarborough, Inc.195-0802020-08-01
B085K077M60Audit MicroControls Control LQ COVID-19 AntibodiesAALTO SCIENTIFICK077M-62020-07-06