BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Phadebact CSF Test

    DI: 07350049850221 · Model: 10-5592-12 · Mkl Diagnostics AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Phadebact CSF Test
    Primary DI
    07350049850221
    Version / Model
    10-5592-12
    Catalog Number
    10-5592-12
    Company Name
    Mkl Diagnostics AB
    Labeler DUNS
    350472667
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-17
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    8337d3db-7df1-4740-97d8-05647a8abf99

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    GTJ Antisera, All Groups, N. Meningitidis

    GMDN Terms

    Code Name
    50399 Multiple meningitis-associated bacteria antigen IVD, kit, agglutination

    Identifiers

    Type ID
    Primary 07350049850221

    Customer Contacts

    Phone
    8002556730
    Email
    [email protected]

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius