BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EL-ANCA: anti-PR3

    Reg #: 1421346 · FEI: 1421346 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    THERATEST LABORATORIES, INC.
    Registration Number
    1421346
    FEI Number
    1421346
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1120 N Du Page Ave
    City
    Lombard
    State
    IL
    ZIP
    60148
    Country
    US

    Regulatory Submissions

    510(k) Number
    K061376

    Owner / Operator

    Firm Name
    TheraTest Labs, Inc.
    Operator Number
    1421346
    Address
    1120 N DuPage Ave, --
    City
    Lombard
    State
    IL
    Postal Code
    60148
    Country
    US
    Correspondent
    Tony - Bowers

    Products

    Device Name Product Code
    Test System, Antineutrophil Cytoplasmic Antibodies (Anca) MOB

    Proprietary Names

    EL-ANCA: anti-PR3 EL-ANCA: anti-MPO

    Establishment Types

    Manufacture Medical Device