BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pre-Hypotonic Solution

    DI: 05060174130083 · Model: GGS - JL007 · GENIAL HELIX LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pre-Hypotonic Solution
    Primary DI
    05060174130083
    Version / Model
    GGS - JL007
    Catalog Number
    GGS - JL007
    Company Name
    GENIAL HELIX LTD
    Labeler DUNS
    219918136
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-18
    Public Version
    1
    Public Version Date
    2023-09-26
    Public Version Status
    New
    Public Device Record Key
    00e113ee-8221-425d-ab7a-c50505d4d5d4

    Device Description

    Pre-Hypotonic Solution is to be used before the hypotonic stage of a blood or bone marrow harvest; pre-hypotonic solution makes the hypotonic step more effective by circumventing the tendency of chromosomes to clump or to under-spread.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KIQ Kit, Culture, Chromosome

    GMDN Terms

    Code Name
    64705 Assay development analyte-specific reagent IVD

    Identifiers

    Type ID
    Primary 05060174130083