BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GROUP A STREPTOCOCCUS

    DI: 15420045506305 · Model: GROUP A STREP DIRECT TEST (GASD) 100T · Hologic, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GROUP A STREPTOCOCCUS
    Primary DI
    15420045506305
    Version / Model
    GROUP A STREP DIRECT TEST (GASD) 100T
    Catalog Number
    103890
    Company Name
    Hologic, Inc.
    Labeler DUNS
    050579217
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-05-02
    Public Version
    4
    Public Version Date
    2023-05-03
    Public Version Status
    Update
    Public Device Record Key
    d2cd030c-990e-4c01-81ae-0b73cedacee5

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    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
    Yes
    PM Exempt
    No
    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
    MDK DNA-PROBE, REAGENTS, STREPTOCOCCAL

    GMDN Terms

    Code Name
    58957 Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 15420045506305

    Premarket Submissions

    Submission Number Supplement Number
    K924715 000