FDA.reportPublic FDA data

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Definition
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 intended to be used for self-testing by a layperson in the home or similar environment.
GUDID devices
160
Last updated
2026-10-17 23:34:01

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08800076701410GenBody COVID-19 Ag Home TestGenbody Inc.COVAGHT2-U-22026-10-08
00850010224480CareSuperb COVID-19 Antigen TestAccess Bio Inc.RCXM-020712026-10-01
00311917080062WalgreensWALGREEN CO.7610162026-08-26
00742860000041OSOM COVID-19 Antigen Home TestSekisui Diagnostics, LLC1067-402024-12-16
50856362005895iHealthiHealth Labs Inc.ICO-30002022-09-16
50856362005901iHealthiHealth Labs Inc.ICO-30002022-09-16
00311917122045WalgreensWALGREEN CO.5052882023-03-09
50850078377369iHealthiHealth Labs Inc.ICO-30002026-07-21
20850044118056iHealthiHealth Labs Inc.ICO-30002022-09-30
50850044118040iHealthiHealth Labs Inc.ICO-30002022-09-30
50850044118064iHealthiHealth Labs Inc.ICO-30002022-09-30
00850044118052iHealthiHealth Labs Inc.ICO-30002022-09-30
00850044118045iHealthiHealth Labs Inc.ICO-30002022-09-30
00194346415908equateWAL-MART STORES, INC.ICO-30002025-05-22
00682607002306Flowflex COVID-19 Antigen Home TestAcon Laboratories, Inc.L031-118B5, L031-125M5, L031-125N5, L031-125P52026-01-26
00816862024630WELLlife™ WONDFO USA CO., LTD.WV01P0001-12024-12-20
00816862024661WELLlife™ WONDFO USA CO., LTD.WV01P0001-22024-12-20
00816862024685WELLlife™ WONDFO USA CO., LTD.WV01P0001-52024-12-20
00816862024708WELLlife™ WONDFO USA CO., LTD.WV01P0001-102024-12-20
00816862024722WELLlife™ WONDFO USA CO., LTD.WV01P0001-252024-12-20
00816862026153WELLlife™WONDFO USA CO., LTD.WV01P0001-2S2024-12-24
00816862026238WELLlife™ WONDFO USA CO., LTD.WL03P0001-22024-11-22
00816862026252WELLlife™ WONDFO USA CO., LTD.WL03P0001-52024-12-20
00816862026276WELLlife™ WONDFO USA CO., LTD.WL03P0001-102024-12-20
00816862026290WELLlife™ WONDFO USA CO., LTD.WL03P0001-252024-12-20
00816862027402WELLlife™ WONDFO USA CO., LTD.WL03P0001-2S2025-07-03
00850042559079CorDxCORETESTS, INC.CO291-22022-12-09
00850042559086CorDxCORETESTS, INC.CO291-52022-12-09
00850042559093CorDxCORETESTS, INC.CO291-102022-12-09
00850042559123CorDxCORETESTS, INC.CO291-22022-12-14
00850042559130CorDxCORETESTS, INC.CO291-52022-12-14
00850042559147CorDxCORETESTS, INC.CO291-102022-12-14
00850042559154CorDxCORETESTS, INC.CO291-82023-01-20
00850042559666CorDx TyfastCORETESTS, INC.ACT21003-2A2024-09-05
00850042559673CorDx TyfastCORETESTS, INC.ACT21003-2B2024-09-04
00850042559918CorDx TyfastCORETESTS, INC.ACT21003-42024-09-04
00850042559925CorDx TyfastCORETESTS, INC.ACT21003-52024-09-05
00850042559932CorDx TyfastCORETESTS, INC.ACT21003-82024-09-05
00850042559949CorDx TyfastCORETESTS, INC.ACT21003-102024-09-05
00850042559956CorDx TyfastCORETESTS, INC.ACT21003-122024-09-05
00850042559963CorDx TyfastCORETESTS, INC.ACT21003-202024-09-05
00850044118069iHealthiHealth Labs Inc.ICO-30002022-09-30
00856362005890iHealthiHealth Labs Inc.ICO-30002022-09-16
00856362005906iHealthiHealth Labs Inc.ICO-30002022-09-16
00860008954824Genabio COVID-19 Rapid Self-Test KitGenabio Diagnostics Inc.RA9-E003252023-04-28
00860008954831Genabio COVID-19 Rapid Self-Test KitGenabio Diagnostics Inc.RA9-E003052023-04-28
00860008954879Genabio COVID-19 Rapid Self-Test KitGenabio Diagnostics Inc.RA9-E003022023-04-27
00895160002786Nano-Check TM COVID-19 Antigen TestNANO-DITECH CORPORATIONMD-81472020-11-18
00895160002793Fluoro-Check TM COVID-19 Antigen TestNANO-DITECH CORPORATIONTF-81502020-11-25
06921963712516Boson - Rapid SARS-CoV-2 Antigen Test Card - 5 Tests/KitXiamen Boson Biotech Co., Ltd.1N40C5-5-US2022-10-08
06921963712523Boson - Rapid SARS-CoV-2 Antigen Test Card - 20 Tests/KitXiamen Boson Biotech Co., Ltd.1N40C5-20-US2022-10-08
06921963712929Boson - Rapid SARS-CoV-2 Antigen Test Card - 8 Tests/KitXiamen Boson Biotech Co., Ltd.1N40C5-8-US2022-09-24
06921963712936Boson - Rapid SARS-CoV-2 Antigen Test Card - 40 Tests/KitXiamen Boson Biotech Co., Ltd.1N40C5-40-US2022-10-08
06921963712943Boson - Rapid SARS-CoV-2 Antigen Test Card - 10 Tests/KitXiamen Boson Biotech Co., Ltd.1N40C5-10-US2022-10-08
06921963712950Boson - Rapid SARS-CoV-2 Antigen Test Card - 4 Tests/KitXiamen Boson Biotech Co., Ltd.1N40C5-4-US2022-10-08
06921963715296Boson - Rapid SARS-CoV-2 Antigen Test Card - 2 Tests/KitXiamen Boson Biotech Co., Ltd.1N40C5-2-US2022-11-08
06930251802365equateWAL-MART STORES, INC.ICO-30002025-04-05
06936700403916Hotgen™ COVID-19 Antigen Home TestBeijing Hotgen Biotech Co., Ltd.2T/Kit2022-12-09
06936700405200Hotgen™ COVID-19 Antigen Home TestBeijing Hotgen Biotech Co., Ltd.1T/kit2022-12-09
06936700405217Hotgen™ COVID-19 Antigen Home TestBeijing Hotgen Biotech Co., Ltd.5T/kit2022-12-09
06936700405224Hotgen™ COVID-19 Antigen Home TestBeijing Hotgen Biotech Co., Ltd.10T/kit2022-12-09
06936700405231Hotgen™ COVID-19 Antigen Home TestBeijing Hotgen Biotech Co., Ltd.20T/kit2022-12-09
06936700405248Hotgen™ COVID-19 Antigen Home TestBeijing Hotgen Biotech Co., Ltd.40T/kit2022-12-09
06942468181676GenabioCore Technology Co.,Ltd.BP291-12022-09-12
06942468181683Genabio Core Technology Co.,Ltd.BP291-52022-09-12
06974541564403BioTekeBioteke Corporation (Wuxi) Co., Ltd.BTK-H22052024-05-27
08800076700222GenBody COVID-19 Ag Home TestGenbody Inc.COVAGHT2-U-22023-02-27
08800076700598GenBody COVID-19 Ag Home TestGenbody Inc.COVAGHT2-U-252023-02-27
08800076700727GenBody COVID-19 Ag Home TestGenbody Inc.COVAGHT2-U-52023-02-27
B115ABCASS2CANAO1Advin COVID-19 Antigen Test @HomeADVIN BIOTECH, INC.ABCass(2)-CAN-AO2023-01-20
B115ABCASS5CANAO1Advin COVID-19 Antigen Test @HomeADVIN BIOTECH, INC.ABCass(5)-CAN-AO2023-01-20
B379CAGS21SCoV-2 Ag Detect™ Rapid Self-TestINBIOS INTERNATIONAL, INCCAGS-22022-12-08
20682607660265Flowflex COVID-19 Antigen Home TestAcon Laboratories, Inc.L031-118B5, L031-125M5, L031-125N5, L031-125P52026-01-26
00810143620122GenaCheck® COVID-19 Rapid Self-Test 2TGenabio Diagnostics Inc.N/A2026-01-21
00810143620382GenaCheck® COVID-19 Rapid Self-Test 20TGenabio Diagnostics Inc.N/A2026-01-21
00810143620399GenaCheck® COVID-19 Rapid Self-Test 4TGenabio Diagnostics Inc.N/A2026-01-21
B379C19S21COVID-19 Detect™ Rapid Self -TestINBIOS INTERNATIONAL, INCC19S-22026-01-16
00850010224275CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.RCTM-001712026-01-05
00850010224305CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.RCTM-002712026-01-05
00850010224435CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.RCTM-005712026-01-05