BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Prolex Staph Kit (100 tests)

    DI: 10628429000394 · Model: PL.080B · PRO-LAB, INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Prolex Staph Kit (100 tests)
    Primary DI
    10628429000394
    Version / Model
    PL.080B
    Catalog Number
    PL.080B
    Company Name
    PRO-LAB, INCORPORATED
    Labeler DUNS
    960418395
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-25
    Public Version
    1
    Public Version Date
    2023-01-02
    Public Version Status
    New
    Public Device Record Key
    4e43bbba-860a-470c-bb1d-2d2d46b6c8a7

    Device Description

    The Prolex™ Staph Latex Kit provides a rapid platform for the identification of Staphylococcal isolates particularly Staphylococcus aureus which possess bound coagulase (clumping factor) and / or protein A from other species of staphylococci

    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
    Yes
    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
    GTN Antisera, Fluorescent, All Types, Staphylococcus Spp.

    GMDN Terms

    Code Name
    62930 Multiple Staphylococcus species nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 10628429000394