BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HEMO BIOSCIENCE

    Reg #: 3017237798 · FEI: 3017237798 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    11
    Establishment Types
    3
    Classifications
    8

    Registration Details

    Registration Name
    HEMO BIOSCIENCE
    Registration Number
    3017237798
    FEI Number
    3017237798
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4022 stirrup creek dr, suite 311
    City
    Durham
    State
    NC
    ZIP
    27703
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK140161

    Owner / Operator

    Firm Name
    Hemo bioscience
    Operator Number
    10090845
    Address
    4022 stirrup creek dr, suite 311
    City
    Durham
    State
    NC
    Postal Code
    27703
    Country
    US
    Correspondent
    noel r brown

    Products

    Device Name Product Code
    Kit, Quality Control For Blood Banking Reagents KSF
    Whole Human Serum, Antigen, Antiserum, Control DGR
    Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use KSX
    Solution, Stabilized Enzyme KSK
    Reagents, Specific, Analyte MVU
    Lectins And Protectins KSI
    Diluent, Blood Cell GIF
    Media, Potentiating For In Vitro Diagnostic Use KSG

    Proprietary Names

    Hemo QC Validation and Competency Kit MQC-CAT Anti-A1 Lectin 0.2M DTT MQC ELUCLEAR ACID ELUTION KIT C3 Control Cells HBS-Lectin Kit Modified Alsevers ATP PEG-XG

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device