BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    InTray® COLOREX Salmonella

    DI: B08812230 · Model: 1223 · BIO-MED DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    InTray® COLOREX Salmonella
    Primary DI
    B08812230
    Version / Model
    1223
    Catalog Number
    21-223-001
    Company Name
    BIO-MED DIAGNOSTICS, INC.
    Labeler DUNS
    605213545
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-12
    Public Version
    1
    Public Version Date
    2018-10-15
    Public Version Status
    New
    Public Device Record Key
    336b8a3b-a6ce-4af2-ab95-6a0b20d0e18d

    Device Description

    A chromogenic medium for selective isolation and differentiation of Salmonella species, (e.g., Enterobacteriaceae and other enteric bacteria).The test can be performed with samples composed of mixed populations of bacteria, e.g stool, blood, biological fluids, surface streaks, etc. High sensitivity and specificity of the medium lead to a higher detection rate of Salmonella spp. Selective agents inhibit the growth of gram-positive organisms. Artificial substrates are metabolized by specific microbial enzymes liberating insoluble chromogenic compounds. Salmonella species produce deep pink to mauve colored colonies. Bacteria other than Salmonella spp. produce blue colonies, or are colorless or inhibited.

    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
    JSI Culture Media, Selective And Differential

    GMDN Terms

    Code Name
    58571 Chromogenic Salmonella species agar culture medium IVD

    Identifiers

    Type ID
    Package B08812234
    Primary B08812230
    Package B08812232

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius