BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Prolex E. coli O157 Latex Test Reagent Kit (100 tests)

    DI: 10628429001056 · Model: PL.071B · PRO-LAB, INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Prolex E. coli O157 Latex Test Reagent Kit (100 tests)
    Primary DI
    10628429001056
    Version / Model
    PL.071B
    Catalog Number
    PL.071B
    Company Name
    PRO-LAB, INCORPORATED
    Labeler DUNS
    960418395
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-26
    Public Version
    1
    Public Version Date
    2023-01-03
    Public Version Status
    New
    Public Device Record Key
    c751a924-dbb9-4996-b582-02f87d6039dc

    Device Description

    ProlexTM E. coli O157 identifies Escherichia coli strains associated with Haemorrhagic Colitis and Haemolytic Uraemic Syndrome. Results can be obtained in two minutes from a single colony taken directly from selective agar. This unique reagent has been developed to remove common cross reactions with other similar "O" and "H" antigens, in particular E. hermanii. Available in 50 and 100 test formats, each kit has a maximum shelf life of two years from date of manufacture, and includes mixing sticks, agglutination cards, positive and negative controls.

    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
    GNA Antisera, All Types, Escherichia Coli

    GMDN Terms

    Code Name
    50913 Escherichia coli antigen IVD, kit, agglutination

    Identifiers

    Type ID
    Primary 10628429001056