BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Premier Bio-Cup and Bio-Dip

    Reg #: 3010934853 · FEI: 3010934853 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    ADVIN BIOTECH, INC.
    Registration Number
    3010934853
    FEI Number
    3010934853
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10140 Mesa Rim Rd., Unit 1
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182123

    Owner / Operator

    Firm Name
    Advin Biotech Inc
    Operator Number
    10046939
    Address
    10140 Mesa Rim Rd., Unit 1
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US
    Correspondent
    Yedda Huang

    Products

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

    Proprietary Names

    Premier Bio-Cup and Bio-Dip ATTEST Drug Screen Cup / Dip Card DrugExam Multi Drug Screen Test Multi Drug Screen Test Pro Cup / Card NexScreen Drug Cup / Dip Card

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device