BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACE HDL-C Reagent (Axcel, plasma)

    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
    K122757

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

    Proprietary Names

    ACE HDL-C Reagent (Axcel, plasma) ACE LDL-C Reagent (Axcel, plasma) ACE Triglycerides Reagent (Axcel, plasma) ACE Cholesterol Reagent (Axcel, plasma)

    Establishment Types

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