BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Prolex Latex Reagent Control Negative (Staph)

    DI: 10628429000431 · Model: PL.085B · PRO-LAB, INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Prolex Latex Reagent Control Negative (Staph)
    Primary DI
    10628429000431
    Version / Model
    PL.085B
    Catalog Number
    PL.085B
    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
    6125ce3f-b880-49c8-bf5f-e562451dec80

    Device Description

    Negative Control Latex Reagent (PL.085B / PL.086B): One dropper bottle containing 2.5 ml (PL.080B) or 7.5 ml (PL.081B) of unsensitized latex particles suspended in a buffer containing 0.098% sodium azide as a preservative

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    51661 Staphylococcus aureus culture isolate antigen IVD, control

    Identifiers

    Type ID
    Primary 10628429000431