BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACE T4 Reagent

    Reg #: 2247288 · FEI: 1000122044 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    ALFA WASSERMANN
    Registration Number
    2247288
    FEI Number
    1000122044
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4 Henderson Dr
    City
    West Caldwell
    State
    NJ
    ZIP
    07006
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131515

    Owner / Operator

    Firm Name
    Alfa Wassermann Diagnostic Technologies, LLC
    Operator Number
    10028192
    Address
    4 Henderson Drive
    City
    West Caldwell
    State
    NJ
    Postal Code
    07006
    Country
    US
    Correspondent
    Allan Gennis

    Products

    Device Name Product Code
    Colorimetric Method, Gamma-Glutamyl Transpeptidase JPZ
    Lipase-Esterase, Enzymatic, Photometric, Lipase CHI
    Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI

    Proprietary Names

    ACE T4 Reagent ACE -GT Reagent ACE Lipase Ragent

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility