BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Bromelin for Erytype

    Reg #: 3004910133 · FEI: 3004910133 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DiaMed GmbH
    Registration Number
    3004910133
    FEI Number
    3004910133
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Pra Rond 23
    City
    Cressier Fribourg
    Country
    CH

    Regulatory Submissions

    510(k) Number
    BK040070

    Owner / Operator

    Firm Name
    Bio-Rad Medical Diagnostics GmbH
    Operator Number
    10032616
    Address
    Industriestrasse 1
    City
    Dreieich
    State
    Hesse
    Postal Code
    63303
    Country
    DE
    Correspondent
    Marc Gorzellik, PH.D.

    US Agent

    Business Name
    Bio-Rad Laboratories
    Contact Name
    David Bhend
    Address
    14620 Ne North Woodinville Way
    City
    Woodinville
    State
    WA
    ZIP
    98072
    Country
    US
    Email
    [email protected]
    Phone
    425 2730193

    Products

    Device Name Product Code
    System, Test, Automated Blood Grouping And Antibody KSZ

    Proprietary Names

    Bromelin for Erytype Bromelin Solidscreen II Control Erytype S ABO Donor Confirmation Erytype S ABD+Rev. A1,B Solidscreen II Negative Control MLB 2 Erytype S Rh Donor Confirmation Erytype S Rh Donor Negative Control Solidscreen II Strip Solidscreen II Erytype S ABO Donor

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198