BEUDAMED
    FDA Registration Active 🇨🇳 China

    LYHER® Urine Multi-Drug Test Kit(Dipcard)

    Reg #: 3016610313 · FEI: 3016610313 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    HANGZHOU LAIHE BIOTECH CO.,LTD.
    Registration Number
    3016610313
    FEI Number
    3016610313
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District
    City
    Hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K232597

    Owner / Operator

    Firm Name
    Hangzhou Laihe Biotech Co.,Ltd.
    Operator Number
    10065287
    Address
    Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District
    City
    Hangzhou
    State
    Zhejiang
    Postal Code
    310051
    Country
    CN
    Correspondent
    Yun Ouyang

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Phencyclidine LCM
    Enzyme Immunoassay, Amphetamine DKZ
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO

    Proprietary Names

    LYHER® Urine Multi-Drug Test Kit(Dipcard) LYHER® Urine Multi-Drug Test Kit(Cassette) Methamphetamine (MET) One step rapid test cassette Phencyclidine (PCP) One step rapid test cassette Opiates(OPI) One step rapid test cassette Marijuana (THC) one step rapid test cassette Phencyclidine (PCP) One step rapid test dipcard Amphetamine (AMP)one step rapid test cassette Cocaine (COC) one step rapid test dipcard Multi drugs one step rapid test kit (MET/THC) Marijuana (THC) one step rapid test dipcard Cocaine (COC) one step rapid test cassette Amphetamine (AMP)one step rapid test dipcard LYHER® Urine Multi-Drug Test Kit(Cup) Opiates(OPI) One step rapid test dipcard Methamphetamine (MET) One step rapid test dipcard

    Establishment Types

    Manufacture Medical Device