FDA.reportPublic FDA data

Fentanyl IVD, kit, rapid ICT, clinical

Definition
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of fentanyl 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.
GUDID devices
75
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00690286000797Labcorp Fentanyl Urine Visual TestMEDTOX DIAGNOSTICS, INC.6060002026-03-31
00695684423384AimScreen FentanylGERMAINE LABORATORIES, INC423382024-04-01
00810164510075Atida Fentanyl Drug of Abuse Test RxACESO LABORATORIES INC.U02-FYL-US2026-03-23
00810164510082Atida Fentanyl Drug of Abuse Test ACESO LABORATORIES INC.U02CW-FYL-US2026-03-23
00810174470888SAFElife™WONDFO USA CO., LTD.DWFTY-OTC1-10BX2025-12-05
00816862024951SAFElife™WONDFO USA CO., LTD.WDFT-201-OTC1-25BX2024-12-24
00816862024975SAFElife™WONDFO USA CO., LTD.WDFT-201-OTC1-10BX 2024-12-24
00816862024999WELLlife™ WONDFO USA CO., LTD.WDFT-201-OTC1-5BX2024-12-24
00816862025873WELLlife™ WONDFO USA CO., LTD.WDFT-201-OTC1-1BX 2024-12-24
00816862025897SAFElife™WONDFO USA CO., LTD.WFTY-OTC1-25BX2024-12-24
00816862025910SAFElife™WONDFO USA CO., LTD.WFTY-OTC1-10BX 2024-12-24
00816862025934SAFElife™WONDFO USA CO., LTD.WFTY-OTC1-5BX 2025-05-22
00816862025958SAFElife™WONDFO USA CO., LTD.WFTY-OTC1-1BX 2024-12-24
00816862026016WELLlife™ WONDFO USA CO., LTD.WDFT-201-POC1W-25BX2024-12-24
00816862026030WELLlife™WONDFO USA CO., LTD.WFTY-POC1W-25BX2024-12-24
00816862026092SAFElife™WONDFO USA CO., LTD.DWFTY-OTC1-5BX2024-12-24
00816862026115SAFElife™WONDFO USA CO., LTD.DWFTY-OTC1-10BX2024-12-24
00816862026139SAFElife™WONDFO USA CO., LTD.DWFTY-OTC1-25BX2024-12-24
00817405024025iCassetteInstant Technologies, Inc.ABTDFYW11201A2023-11-30
00850076289034HYSEN Fentanyl Rapid TestHYSEN INC.HFYL-102A2025-08-28
06936983138642AllTest Fentanyl Rapid Test (Urine)Hangzhou AllTest Biotech Co., Ltd.DFY-A1022023-08-22
06936983138840AllTest Fentanyl Rapid TestHangzhou AllTest Biotech Co., Ltd.12026-04-16
06936983144070AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd.12026-04-16
06936983144087AlltestHangzhou AllTest Biotech Co., Ltd.DFY-A102C2023-11-30
06936983144568AllTest Hangzhou AllTest Biotech Co., Ltd.DFY-A102C (1ng)2023-11-30
06936983172325AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd.12026-04-14
06942598203194AllTest Fentanyl Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.12026-04-13
10722066007706Rapid ResponseBTNX IncFYL-1C156-252024-02-22
10722066008246Rapid ResponseBTNX IncFYL-1CAP1562024-08-14
10722066008628Rapid ResponseBTNX Inc FYL-1CAP1562024-08-14
16936983143445Alltest Hangzhou AllTest Biotech Co., Ltd.121151-1-442023-11-20
16936983144640CLIA waived,Inc. Rapid Drug Test Device “RDTD” for Fentanyl in UrineHangzhou AllTest Biotech Co., Ltd.DFY-A102C2023-11-30
16936983144855DiscoverHangzhou AllTest Biotech Co., Ltd.DISP-CLIAFEN$2023-11-30
16936983149430Identify Fentanyl Rapid CassetteHangzhou AllTest Biotech Co., Ltd.DFY-A102C A32182024-02-08
00810164510099Atida Fentanyl Test ACESO LABORATORIES INC.U02ST-FYL-US2026-03-23
80810164510071Atida Fentanyl Drug of Abuse Test RxACESO LABORATORIES INC.U02-FYL-US2026-03-23
80810164510088Atida Fentanyl Drug of Abuse Test ACESO LABORATORIES INC.U02CW-FYL-US2026-03-23
06977469280431ETERBIO Fentanyl/Norfentanyl Home TestEterbio, Inc.ETG0010032025-12-08
00810174470871SAFElife™WONDFO USA CO., LTD.DWFTY-OTC1-10BX2025-12-05
10850076289031HYSEN Fentanyl Rapid TestHYSEN INC.HFYL-102A2025-08-28
10816862025931SAFElife™WONDFO USA CO., LTD.WFTY-OTC1-5BX 2025-05-22
10816862024958SAFElife™WONDFO USA CO., LTD.WDFT-201-OTC1-25BX2024-12-24
10816862024972SAFElife™WONDFO USA CO., LTD.WDFT-201-OTC1-10BX 2024-12-24
10816862024996WELLlife™ WONDFO USA CO., LTD.WDFT-201-OTC1-5BX2024-12-24
10816862025870WELLlife™ WONDFO USA CO., LTD.WDFT-201-OTC1-1BX 2024-12-24
10816862025894SAFElife™WONDFO USA CO., LTD.WFTY-OTC1-25BX2024-12-24
10816862025917SAFElife™WONDFO USA CO., LTD.WFTY-OTC1-10BX 2024-12-24
10816862025955SAFElife™WONDFO USA CO., LTD.WFTY-OTC1-1BX 2024-12-24
10816862026013WELLlife™ WONDFO USA CO., LTD.WDFT-201-POC1W-25BX2024-12-24
10816862026037WELLlife™WONDFO USA CO., LTD.WFTY-POC1W-25BX2024-12-24
10816862026099SAFElife™WONDFO USA CO., LTD.DWFTY-OTC1-5BX2024-12-24
10816862026112SAFElife™WONDFO USA CO., LTD.DWFTY-OTC1-10BX2024-12-24
10816862026136SAFElife™WONDFO USA CO., LTD.DWFTY-OTC1-25BX2024-12-24
00722066008249Rapid ResponseBTNX IncFYL-1CAP1562024-08-14
00722066008621Rapid ResponseBTNX Inc FYL-1CAP1562024-08-14
06974246461496FIRSTVIEW Fentanyl Urine Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.5 tests2024-06-28
10695684423381AimScreen FentanylGERMAINE LABORATORIES, INC423382024-04-01
06936983148504Discover Fentanyl Rapid Tes CassetteHangzhou AllTest Biotech Co., Ltd.DFY-A102H A16172024-02-08
069369831493102SAN Fentanyl Rapid Tes CassetteHangzhou AllTest Biotech Co., Ltd.DFY-A102H A25532024-02-08
06936983149426Identify Fentanyl Rapid CassetteHangzhou AllTest Biotech Co., Ltd.DFY-A102H A32182024-02-08
06936983149433Identify Fentanyl Rapid CassetteHangzhou AllTest Biotech Co., Ltd.DFY-A102C A32182024-02-08
30817405024026iCassetteInstant Technologies, Inc.ABTDFYW11201A2023-11-30
06936983143370AlltestHangzhou AllTest Biotech Co., Ltd.DFY-A102C2023-11-30
06936983143950Alltest Hangzhou AllTest Biotech Co., Ltd.DFY-A102H2023-11-30
06936983144551AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd.12026-04-16
06936983144650Alltest Hangzhou AllTest Biotech Co., Ltd.DFY-A102H2023-11-30
06936983144643CLIA waived,Inc. Rapid Drug Test Device “RDTD” for Fentanyl in UrineHangzhou AllTest Biotech Co., Ltd.DFY-A102C2023-11-30
06936983144858DiscoverHangzhou AllTest Biotech Co., Ltd.DISP-CLIAFEN$2023-11-30
06936983143448Alltest Hangzhou AllTest Biotech Co., Ltd.121151-1-442023-11-20
00850054026323InstaTest™Diagnostic Automation, Inc.DACD121151-1-442023-10-06
06936983136495AllTest Fentanyl Rapid Test (Urine)Hangzhou AllTest Biotech Co., Ltd.DFY-A1022023-08-22
06936983138857AllTest Fentanyl Rapid TestHangzhou AllTest Biotech Co., Ltd.12026-04-16
06974521002239S-Trust Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay)Shenzhen Superbio Technology Co., Ltd.25 Tests/Kit2023-03-22
06974521006619U-Catch Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay)Shenzhen Superbio Technology Co., Ltd.25 Tests/Kit2023-03-22
00817302022346Carolina Liquid Chemistries Corp. Fentanyl Detection KitCAROLINA LIQUID CHEMISTRIES CORPORATIONCLCF0650252023-03-10