BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medline Drug Test Cup

    Reg #: 3007606081 · FEI: 3007606081 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    51
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    WONDFO USA CO., LTD.
    Registration Number
    3007606081
    FEI Number
    3007606081
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    890 Remington Blvd
    City
    Bolingbrook
    State
    IL
    ZIP
    60440
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182701

    Owner / Operator

    Firm Name
    Wondfo USA Co., Ltd.
    Operator Number
    10028951
    Address
    890 REMINGTON BLVD
    City
    Bolingbrook
    State
    IL
    Postal Code
    60440
    Country
    US
    Correspondent
    Kunyuan Mao

    Products

    Device Name Product Code
    Test, Cannabinoid, Over The Counter NFW
    Test, Amphetamine, Over The Counter NFT
    Enzyme Immunoassay, Phencyclidine LCM
    Test, Opiates, Over The Counter NGL
    Test, Benzodiazepine, Over The Counter NFV
    Test, Methadone, Over The Counter PTG
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Propoxyphene, Over The Counter QBF
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Barbiturate, Over The Counter PTH
    Test, Methamphetamine, Over The Counter NGG

    Proprietary Names

    Medline Drug Test Cup Micro Distributing II, Ltd, STAT Cup One Step Drug Test Guangzhou Wondfo Biotech Co., Wondfo VacuLid Multi-Drug Urine Test Cup Guangzhou Wondfo Co., Ltd., Wondfo Multi-Drug Urine Rx Test Cup Areta Multi-Drug Test Cup Alere Toxicology Services, Alere T-Cup Compact Multi-Drug Urine Test Cup T-Cup Multi-Drug Urine Test Cup Wondfo USA Co., Ltd. T-Cup Flat Multi-Drug Urine Test Cup RST Home Drug Test Kit Cup (Urine) Easy Healthcare Corporation, Easy@Home Drug Test Cup Wondfo USA Co., Ltd. Q-Cup Multi-Drug Urine Test Cup Alere Toxicology Services, UScreen Drug Test Cup Magenta Multi-Drug Urine Test Cup, Magenta Multi-Drug Urine Test Compact Cup Areta Multi-Drug Test Cup, ACDOA-264 Easy@Home Drug Test Cup, ECDOA-6125B iSCREEN™ URINE TEST DRUG SCREEN SQUARE CUP Easy@Home Drug Test Cup, ECDOA-1144A3 Multi-Drug Test Cup iSCREEN™ ORAL FLUID TEST DRUG SCREEN CUBE IDT Multi Drug Urine Test Cup SAFElife™ F-Cup Multi-Drug Urine Test Cup iSCREEN™ URINE TEST DX DRUG SCREEN SQUARE CUP STATCUP® II One Step Drug Test QTEST™ Multi-Drug Urine Test Compact Cup IDT Multi Drug Urine Test Compact Cup Drug Test Cup Clarity Multi-Drug Urine Test Cup (Urine) SAFElife™ T-Cup Multi-Drug Urine Test Cup SAFElife™ S-Cup Multi-Drug Urine Test Cup UA Multi-Drug Urine Test Cup Prime Screen One Step Multi-Drug Oral Fluid Test iSCREEN™ URINE TEST DX DRUG SCREEN ROUND CUP STATCUP® One Step Drug Test Easy@Home Drug Test Cup, ECDOA-254 CheckNow Multi - Drug Urine Test Cup Areta Multi-Drug Test Cup, ACDOA-6125B PRIME SCREEN® Multi-Drug Urine Test Cup T-Cup® Multi-Drug Urine Test Cup easy@Home Drug Test Cup, ECDOA3-6125B 2SAN Home Drug Test Kit Easy@Home Drug Test Cup, ECDOA-7124 SAFElife™ C-Cup Multi-Drug Urine Test Cup Areta Multi-Drug Test Cup, ACDOA-1144 iSCREEN™ URINE TEST DX DRUG SCREEN COMPACT ROUND CUP Areta Multi-Drug Test Cup, ACDOA-754 T-Cup Compact Multi-Drug Urine Test Cup, CDOA-6125 T-Cup® Compact Multi-Drug Urine Test Cup easy@Home® Drug Test Cup BluRapids® MULTI-DRUG TEST CUP Easy@Home® Drug Test Cup INDICAID™ Multi-Drug Urine Test Cup

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198