BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IMMUCOR, INC.

    Reg #: 1034569 · FEI: 1034569 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    51
    Establishment Types
    3
    Classifications
    15

    Registration Details

    Registration Name
    IMMUCOR, INC.
    Registration Number
    1034569
    FEI Number
    1034569
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3130 GATEWAY DR.
    City
    Norcross
    State
    GA
    ZIP
    30071
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK110067

    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, Screening, For D Positive Fetal Rbc'S LIM
    Micro Pipette JRC
    Blood Establishment Computer Software And Accessories MMH
    Solution, Stabilized Enzyme KSK
    Kit, Quality Control For Blood Banking Reagents KSF
    Supplies, Blood-Bank KSS
    System, Test, Automated Blood Grouping And Antibody KSZ
    Ph Buffer JCC
    Antigen, Iha, Cytomegalovirus LJO
    Lectins And Protectins KSI
    Media, Potentiating For In Vitro Diagnostic Use KSG
    Reagent, Rickettsia Serological LSQ
    Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use KSX
    Diluent, Blood Cell GIF
    Test, Donor, Cmv MZE

    Proprietary Names

    FMH RapidScreen Blood Bank Droppers ImmuLINK FDP (Freeze Dried Papain) Galileo QC Cell Segment Sampler Weak D Cells Galileo Echo Rh-Hr Control PHIX WB corQC Capture-P Test System W.A.R.M. Capture-R Select Capture Positive Control Cell (Component of Capture-R Ready-Screen (3) and Ready-ID) Checkcell Checkcell (Weak) DAT Positive Control Cell NEO Iris Galileo Capture-CMV Anti-H Lectin Gamma EGA Kit Complement Control Cells corQC EXTEND Gamma N-HANCE GammaZyme-B GammaZyme-F (BK870014/BK870041) RESt (Rabbit Erythrocyte Stroma) Gamma-clone Control Capture-P Ready Screen Test System Gamma LO-ION Galileo NEO P1 Blood Group Substance Gamma ELU-Kit II Bovine Albumin 22% ImmuAdd ImmuLINK (v3.2) Echo Lumena Capture-R Ready Indicator Red Cells Red Blood Cell (RBC) Storage Solution ImmuLINK (v3.3) Galileo Neo Galileo Neo (v3.1) Gamma-Quin corQC Test System Gamma PeG Anti-A1 Lectin Lewis Blood Group Substance Monoclonal Control PWSS

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device