BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SAS Sickle Cell Test

    DI: 00780311000431 · Model: 094100 · SA SCIENTIFIC, LTD.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SAS Sickle Cell Test
    Primary DI
    00780311000431
    Version / Model
    094100
    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
    245f4058-2224-4895-b34a-84f971f03fbf

    Device Description

    The SAS™ Sickle Cell Test is intended to be used as an aid in the qualitative detection of hemoglobin S (Hb-S) in anticoagulated whole blood. The test does not distinguish between sickle cell disease (HbSS) and sickle cell trait (HbSA). This test is not recommended for use on newborns under 3 months of age. This test is for professional use.

    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
    55906 Haemoglobin S (HbS) IVD, reagent

    Identifiers

    Type ID
    Primary 00780311000431