BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioSign® Strep A card

    DI: 10743816000815 · Model: BSP-182-25-02 · PRINCETON BIOMEDITECH CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BioSign® Strep A card
    Primary DI
    10743816000815
    Version / Model
    BSP-182-25-02
    Catalog Number
    BSP-182-25-02
    Company Name
    PRINCETON BIOMEDITECH CORPORATION
    Labeler DUNS
    362917692
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    c30bf667-9d92-4375-8c58-05ed1c5b18c5

    Device Description

    BioSign® Strep A card; Flip cassette; 25 Test kit

    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
    No
    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
    GTY Antigens, All Groups, Streptococcus Spp.

    GMDN Terms

    Code Name
    51707 Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

    Identifiers

    Type ID
    Primary 10743816000815

    Customer Contacts

    Phone
    7322741000
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius