BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Immucor GTI Diagnostics, Inc.

    Reg #: 2183608 · FEI: 2183608 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    33
    Establishment Types
    4
    Classifications
    5

    Registration Details

    Registration Name
    Immucor GTI Diagnostics, Inc.
    Registration Number
    2183608
    FEI Number
    2183608
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    20925 Crossroads Cir
    City
    Waukesha
    State
    WI
    ZIP
    53186
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201570

    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
    Test, Qualitative, For Hla, Non-Diagnostic MZI
    Platelet Factor 4 Radioimmunoassay LCO
    General Purpose Reagent PPM
    Test, Platelet Antibody MYP
    Test, Qualitative And Quantitative Factor Deficiency GGP

    Proprietary Names

    LIFECODES HLA-NULL Allele SSO Typing Kit LIFECODES LSA Class I LIFECODES C3d Detection LIFECODES LSA Class II PF4 Enhanced assay MatchX LIFECODES LifeScreen XP LIFECODES HLA-DQB1 SSO Typing Kit LIFECODES HLA-B eRES SSO Typing Kit LIFECODES HLA-A eRES SSO Typing Kit LIFECODES HLA-DRB1 SSO Typing Kit LIFECODES HLA-A SSO Typing Kit LIFECODES HLA-C eRES SSO Typing Kit LIFECODES HLA-B SSO Typing Kit LIFECODES HLA-DRB 3,4,5 SSO Typing Kit LIFECODES HLA-DRB1 eRES SSO Typing Kit LIFECODES LifeScreen Deluxe LIFECODES Serum Cleaner Streptavidin-PE (SAPE) LIFECODES Taq Polymerase MATCH IT! Antibody THROMBOTYPE 1 (HPA 1) Factor VIII Antibody Screen DonorScreen-HLA Class I and Class II Additional Reagents DonorScreen-HLA Class I and Class II Concentrated Wash (10X) PakPlus® Assay LIFECODES ID Class IIv2: Luminex 100 screening assay for qualitative detection of IgG panel reactive antibodies (PRA) LIFECODES ID Class I: Luminex 100 screening assay for detection of IgG panel reactive antibodies (PRA) MATCH IT! DNA (version 1.3) PF4 IgG assay LIFECODES HLA-DPA1/B1 SSO Typing Kit LIFECODES HLA-DQA1/B1 SSO Typing Kit

    Establishment Types

    Manufacture Device in the United States for Export Only Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device