BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Polyvalent Somatic Salmonella Antisera - Polyvalent O A-1+Vi

    DI: 05060472461919 · Model: PL.6000 · PRO-LAB, INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Polyvalent Somatic Salmonella Antisera - Polyvalent O A-1+Vi
    Primary DI
    05060472461919
    Version / Model
    PL.6000
    Catalog Number
    PL.6000
    Company Name
    PRO-LAB, INCORPORATED
    Labeler DUNS
    960418395
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-22
    Public Version
    1
    Public Version Date
    2022-12-30
    Public Version Status
    New
    Public Device Record Key
    e6462fad-187c-4efd-85d3-a579f96abd71

    Device Description

    A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.

    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
    GRM Antisera, All Groups, Salmonella Spp.

    GMDN Terms

    Code Name
    51538 Multiple Salmonella species total antibody IVD, reagent

    Identifiers

    Type ID
    Primary 05060472461919