BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HDL Cholesterol Reagent Kit

    Reg #: 1064608 · FEI: 3003071743 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    JAS Diagnostics/Drew Scientific
    Registration Number
    1064608
    FEI Number
    3003071743
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6600 NW 14th Street, BAY 12
    City
    Plantation
    State
    FL
    ZIP
    33313
    Country
    US

    Regulatory Submissions

    510(k) Number
    K021671

    Owner / Operator

    Firm Name
    JAS Diagnostics/Drew Scientific
    Operator Number
    9042128
    Address
    6600 NW 14th Street, BAY 12
    City
    Plantation
    State
    FL
    Postal Code
    33313
    Country
    US
    Correspondent
    Jean F LaCroix

    Products

    Device Name Product Code
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
    Calibrator, Multi-Analyte Mixture JIX

    Proprietary Names

    HDL Cholesterol Reagent Kit Lipid Control Lipid Calibrator

    Establishment Types

    Repack or Relabel Medical Device