BEUDAMED
    FDA Registration Active 🇺🇸 United States

    E. HISTOLYTICA II

    Reg #: 1122855 · FEI: 1000123404 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TECHLAB, INC.
    Registration Number
    1122855
    FEI Number
    1000123404
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2001 KRAFT DRIVE
    City
    BLACKSBURG
    State
    VA
    ZIP
    24060
    Country
    US

    Regulatory Submissions

    510(k) Number
    K994101

    Owner / Operator

    Firm Name
    TECHLAB, INC.
    Operator Number
    9001581
    Address
    2001 KRAFT DRIVE
    City
    Blacksburg
    State
    VA
    Postal Code
    24060
    Country
    US
    Correspondent
    DONNA T LINK

    Products

    Device Name Product Code
    Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. KHW

    Proprietary Names

    E. HISTOLYTICA II

    Establishment Types

    Manufacture Medical Device