BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)

    DI: 14719874742901 · Model: R11 Plus Package-10 tests-US-BR · BONRAYBIO CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)
    Primary DI
    14719874742901
    Version / Model
    R11 Plus Package-10 tests-US-BR
    Catalog Number
    R11 Plus
    Company Name
    BONRAYBIO CO., LTD.
    Labeler DUNS
    658872369
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-02-16
    Public Version
    1
    Public Version Date
    2025-02-24
    Public Version Status
    New
    Public Device Record Key
    94db9649-525d-4207-9027-752546ab6b3d

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    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
    KQC Stains, Hematology

    GMDN Terms

    Code Name
    43587 Biological stain IVD

    Identifiers

    Type ID
    Primary 14719874742901