BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    StrepAim

    DI: 00695684755256 · Model: 75525 · GERMAINE LABORATORIES, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    25

    Basic Information

    Brand Name
    StrepAim
    Primary DI
    00695684755256
    Version / Model
    75525
    Company Name
    GERMAINE LABORATORIES, INC
    Labeler DUNS
    176458115
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2023-01-17
    Public Version
    1
    Public Version Date
    2023-01-25
    Public Version Status
    New
    Public Device Record Key
    62f69dd1-5ffc-42e4-a0a6-c3be369d8f34

    Device Description

    A rapid dipstick test for the qualitative detection of group A streptococcal antigen from throat swabs

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GTY Antigens, All Groups, Streptococcus Spp.

    GMDN Terms

    Code Name
    30493 Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Unit of Use 00695684755201
    Primary 00695684755256