BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PF4 IgG assay

    Reg #: 2183608 · FEI: 2183608 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Immucor GTI Diagnostics, Inc.
    Registration Number
    2183608
    FEI Number
    2183608
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    20925 Crossroads Cir
    City
    Waukesha
    State
    WI
    ZIP
    53186
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201311

    Owner / Operator

    Firm Name
    IMMUCOR, INC.
    Operator Number
    1034569
    Address
    3130 GATEWAY DR.
    City
    Norcross
    State
    GA
    Postal Code
    30071
    Country
    US

    Products

    Device Name Product Code
    Platelet Factor 4 Radioimmunoassay LCO

    Proprietary Names

    PF4 IgG assay

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device