BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SAS Legionella Controls

    DI: 00780311000141 · Model: 044413 · SA SCIENTIFIC, LTD.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SAS Legionella Controls
    Primary DI
    00780311000141
    Version / Model
    044413
    Company Name
    SA SCIENTIFIC, LTD.
    Labeler DUNS
    122092117
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-02
    Public Version
    1
    Public Version Date
    2018-12-03
    Public Version Status
    New
    Public Device Record Key
    de306e16-90b1-40c1-a8bc-2ca7f76d633d

    Device Description

    SAS™ Legionella Controls are for use in monitoring the in vitro diagnostic performance of the SAS™ Legionella Test presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine; their performance has not been evaluated with other Legionella assays. These controls are for prescription 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
    51058 Legionella pneumophila antigen IVD, control

    Identifiers

    Type ID
    Primary 00780311000141