BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACE Cholesterol Reagent

    Reg #: 2247288 · FEI: 1000122044 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    4

    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
    K113262

    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
    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
    System, Test, Low Density, Lipoprotein MRR
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS

    Proprietary Names

    ACE Cholesterol Reagent ACE HDL-C Reagent ACE Triglycerides Reagent ACE LDL-C Reagent

    Establishment Types

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