BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VARIANT II B-thalassemia

    DI: 00847817000447 · Model: 270-2154 · BIO-RAD LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VARIANT II B-thalassemia
    Primary DI
    00847817000447
    Version / Model
    270-2154
    Catalog Number
    2702154
    Company Name
    BIO-RAD LABORATORIES, INC.
    Labeler DUNS
    132528295
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-12
    Public Version
    7
    Public Version Date
    2023-01-31
    Public Version Status
    Update
    Public Device Record Key
    63ea6b83-d8eb-4b03-a569-4547cd87504f

    Device Description

    VARIANT II B-thalassemia Short Program Reorder Pack

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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
    61759 Inherited haemoglobinopathy IVD, kit, liquid chromatography

    Identifiers

    Type ID
    Primary 00847817000447

    Customer Contacts

    Phone
    +1(800)224-6723
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K991127 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius