BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    PerFix NC Kit (Lysing Reagent)

    Reg #: 3002721051 · FEI: 3002721051 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Beckman Coulter GmbH
    Registration Number
    3002721051
    FEI Number
    3002721051
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Europark Fichtenhain B 13
    City
    Krefeld North Rhine-Westphalia
    Country
    DE

    Owner / Operator

    Firm Name
    BECKMAN COULTER, INC.
    Operator Number
    2050012
    Address
    250 S. Kraemer Blvd, --
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US
    Correspondent
    David G Davis

    US Agent

    Business Name
    Beckman Coulter, Inc.
    Contact Name
    David Davis
    Address
    250 S. Kraemer Blvd
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US
    Email
    [email protected]
    Phone
    469 2368180

    Products

    Device Name Product Code
    Products, Red-Cell Lysing Products GGK

    Proprietary Names

    PerFix NC Kit (Lysing Reagent) IRIS BODY FLUIDS LYSING REAGENT OptiLyse C : Lysing Solution AQUIOS Lysing Reagent Kit IntraPrep VersaLyse : Lysing Solution Fixative Solution (10X) Lysing Solution (10X) IOTest 3 Lyse Reagent 2: Permeabilization IOTest 3 Fixative DxH 500 Series Lyse (PN B36846) DxH Cell Lyse 1L & 5L COULTER Rinsol Cleaning Agent DxH ECO Cell Lyse (5L) AcT 5diff Hgb Lyse IMMUNOPREP REAGENT Whole Blood Lysing Reagent COULTER DxH Cell Lyse AcT 5diff WBC Lyse DxH Retic Pack DxH diff Pack AcT 5diff Fix DxH ECO Cell Lyse (1L) Access Red Blood Cell Folate Lysing Agent Access Red Blood Cell Folate Lysing Agent (P/N: A14206 CA MFG)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)