BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    INSTI HIV-1/HIV-2 Control Test Kit

    Reg #: 3003871407 · FEI: 3003871407 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOLYTICAL LABORATORIES INC.
    Registration Number
    3003871407
    FEI Number
    3003871407
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    406 - 13251 Delf Place
    City
    Richmond British Columbia
    Country
    CA

    Regulatory Submissions

    PMA Number
    BP090032

    Owner / Operator

    Firm Name
    Biolytical Laboratories Inc.
    Operator Number
    10038129
    Address
    406 - 13251 Delf Place
    City
    Richmond
    State
    British Columbia
    Postal Code
    V6V 2A2
    Country
    CA

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Road, Building 1, Suite 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Test, Hiv Detection MZF

    Proprietary Names

    INSTI HIV-1/HIV-2 Control Test Kit INSTI HIV-1, Control Test Kit INSTI HIV-1/2 Antibody Test Kit (INSTI)

    Establishment Types

    Manufacture Medical Device