BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Prolex E. coli Non-O157 Identification Kit

    DI: 10628429001124 · Model: PL.1070 · PRO-LAB, INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Prolex E. coli Non-O157 Identification Kit
    Primary DI
    10628429001124
    Version / Model
    PL.1070
    Catalog Number
    PL.1070
    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
    58093b9e-727a-4766-814b-09cd2d1e2284

    Device Description

    The ProlexTM E. coli Non-O157 Kit provides an easy to use, reliable and affordable way to identify the six most common STEC producing serotypes in North America. The kit uses our blue carboxylated latex particles labelled with antibodies to E. coli O26, E. coli O45, E. coli O103, E. coli O111, E. coli O121 and E. coli O145 to perform a simple agglutination test. This kit is a great addition to our line of products for the detection of STEC especially when used in conjunction with our ProlisaTM EHEC EIA Kit (PL.2001) and the ProlexTM E.coli O157 Latex Agglutination Kit (PL.070B and PL.071B). Each non-O157 kit comes with a negative control and sufficient agglutination cards and mixing sticks.

    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 10628429001124