BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HYSEN INC

    Reg #: 3036649420 · FEI: 3036649420 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    22

    Registration Details

    Registration Name
    HYSEN INC
    Registration Number
    3036649420
    FEI Number
    3036649420
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    201 E 5th St Ste 1900
    City
    Cincinnati
    State
    OH
    ZIP
    45202
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131811

    Owner / Operator

    Firm Name
    Hysen Inc
    Operator Number
    10092937
    Address
    201 E Fifth Street, Suite 1900
    City
    Cincinnati
    State
    OH
    Postal Code
    45202
    Country
    US
    Correspondent
    Song Han

    Products

    Device Name Product Code
    Enzyme Immunoassay, Barbiturate DIS
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Phencyclidine LCM
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Methadone DJR
    Enzyme Immunoassay, Propoxyphene JXN
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Benzodiazepine JXM
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Amphetamine, Over The Counter NFT
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Methamphetamine, Over The Counter NGG
    Test, Opiates, Over The Counter NGL
    Test, Benzodiazepine, Over The Counter NFV
    Test, Propoxyphene, Over The Counter QBF
    Test, Methadone, Over The Counter PTG
    Test, Cannabinoid, Over The Counter NFW
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Barbiturate, Over The Counter PTH

    Proprietary Names

    UCP COMPACT DRUG TEST CUPS UCP COMPACT DRUG TEST CARDS Assure Tech. (Hangzhou) Co., Ltd DOA CUP Assure Tech. (Hangzhou) Co., Ltd DOA CARDS

    Establishment Types

    Repack or Relabel Medical Device