BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Cal-Lyse™ Lysing Solution 250 Tests

    DI: 10190302008877 · Model: GAS010 · LIFE TECHNOLOGIES CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cal-Lyse™ Lysing Solution 250 Tests
    Primary DI
    10190302008877
    Version / Model
    GAS010
    Company Name
    LIFE TECHNOLOGIES CORPORATION
    Labeler DUNS
    080131636
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-31
    Public Version
    4
    Public Version Date
    2022-06-03
    Public Version Status
    Update
    Public Device Record Key
    0e786940-1db7-4afc-a554-e36fbcb61e90
    Distribution End Date
    2022-05-31

    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
    GGK PRODUCTS, RED-CELL LYSING PRODUCTS

    GMDN Terms

    Code Name
    57006 CD64 cell marker IVD, antibody

    Identifiers

    Type ID
    Primary 10190302008877