BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    BIO-RAD MEDICAL DIAGNOSTICS GMBH

    Reg #: 9610824 · FEI: 3002806595 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    39
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Registration Number
    9610824
    FEI Number
    3002806595
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Industrie Str. 1
    City
    DREIEICH Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    BK130070

    Owner / Operator

    Firm Name
    DiaMed GmbH (Bio-Rad Laboratories)
    Operator Number
    10032616
    Address
    Pra Rond 23
    City
    Cressier
    State
    Fribourg
    Postal Code
    1785
    Country
    CH
    Correspondent
    Jeremy Poropane

    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
    Media, Potentiating For In Vitro Diagnostic Use KSG
    System, Test, Automated Blood Grouping And Antibody KSZ
    Kit, Quality Control For Blood Banking Reagents KSF
    Manual Blood Grouping And Antibody Test Systems PBC
    Solution, Stabilized Enzyme KSK
    Diluent, Blood Cell GIF
    Blood Establishment Computer Software And Accessories MMH

    Proprietary Names

    MLB2 IH-1000 IH-Card Control Erytype S Rh Donor Erytype S Rh Donor Confirmation MLB 2 Solidscreen II Solidscreen II Negative Control Solidscreen II Control Erytype S ABO Donor Bromelin Bromelin for Erytype Solidscreen II Strip Negative Control Erytype S ABO Donor Confirmation Erytype S ABD+Rev. A1,B IH-Incubator L IH-500 IH-Centrifuge L IH-Papain IH-LISS Solution IH-Titration Solution IH-LISS Rack IH-Titration Rack IH-Reader 24 Washing Solution Concentrate Alsevers Solution Solidscreen II Control B Erytype S Rh+K Type IH-Card Neutral Coombscell-E Seraclone Control ABO+Rh IH-Card ABO Neutral IH-Com Wash Solution A Concentrate IH-Internal QC IH-Basic QC IH-AbID TANGO infinity

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility