BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SAS StrepAlert

    DI: 00780311000448 · Model: 611530 · SA SCIENTIFIC, LTD.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SAS StrepAlert
    Primary DI
    00780311000448
    Version / Model
    611530
    Company Name
    SA SCIENTIFIC, LTD.
    Labeler DUNS
    122092117
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-01
    Public Version
    1
    Public Version Date
    2018-12-03
    Public Version Status
    New
    Public Device Record Key
    9371d621-3b2c-4d4b-9682-00c62d184c6f

    Device Description

    The SAS™ StrepAlert is a rapid visual test for the presumptive qualitative detection of Group A streptococcal antigen from throat swab specimens. The test is for professional use only.

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    61990 Streptococcus pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00780311000448