BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    BIO-RAD MEDICAL LABORATORIES LOGISTIK GMBH

    Reg #: 3016014873 · FEI: 3016014873 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    30
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    BIO-RAD MEDICAL LABORATORIES LOGISTIK GMBH
    Registration Number
    3016014873
    FEI Number
    3016014873
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Eschenallee 5
    City
    Grosskugel /Kabelsketal Saxony-Anhalt
    Country
    DE

    Regulatory Submissions

    510(k) Number
    BK080013

    Owner / Operator

    Firm Name
    Bio-Rad Laboratories (Bio-Rad Services France)
    Operator Number
    10078397
    Address
    Rue Gustave Eiffel
    City
    MITRY-MORY
    State
    Ile-de-France
    Postal Code
    77290
    Country
    FR
    Correspondent
    Lucie Watremetz

    US Agent

    Business Name
    Bio-Rad Laboratories
    Contact Name
    David Bhend
    Address
    6565 185th Ave Ne
    City
    Redmond
    State
    WA
    ZIP
    98052
    Country
    US
    Email
    [email protected]
    Phone
    425 4981758

    Products

    Device Name Product Code
    System, Test, Automated Blood Grouping And Antibody KSZ
    Kit, Quality Control For Blood Banking Reagents KSF
    Solution, Stabilized Enzyme KSK
    Diluent, Blood Cell GIF
    Media, Potentiating For In Vitro Diagnostic Use KSG

    Proprietary Names

    Erytype S Rh+K Type Solidscreen II Control B Solidscreen II Negative Control Alsevers Solution Coombscell-E Seraclone Control ABO+Rh MLB 2 IH-Papain IH-Card Neutral Wash Solution A Concentrate Erytype S ABD+Rev. A1,B Negative Control Bromelin for Erytype Solidscreen II Control Solidscreen II Solidscreen II Strip Bromelin Erytype S ABO Donor Erytype S ABO Donor Confirmation Erytype S Rh Donor Confirmation Erytype S Rh Donor IH-Internal QC Washing Solution Concentrate IH-Basic QC IH-Card Control IH-Titration Solution IH-Liss Solution IH-Liss Rack IH-Titration Rack IH-Card ABO Neutral

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device