BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    G7 β-Thalassemia Elution Buffer Kit

    DI: 04560189283503 · Model: N/A · TOSOH CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    G7 β-Thalassemia Elution Buffer Kit
    Primary DI
    04560189283503
    Version / Model
    N/A
    Company Name
    TOSOH CORPORATION
    Labeler DUNS
    690571724
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    d8f5a140-fa3d-4c6a-8ee9-17c453240598

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JPD Hemoglobin A2 Quantitation

    GMDN Terms

    Code Name
    55900 Haemoglobin F (HbF) IVD, reagent
    55883 Haemoglobin A2 (HbA2) IVD, reagent

    Identifiers

    Type ID
    Primary 04560189283503

    Customer Contacts

    Phone
    614-317-1909
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    4 – 25 Degrees Celsius