BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    InTray® Malt Extract Agar

    DI: B08813330 · Model: 1333 · 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® Malt Extract Agar
    Primary DI
    B08813330
    Version / Model
    1333
    Catalog Number
    21-333-001
    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
    71663494-8f19-4160-a8d3-56b5970545ee

    Device Description

    A nutrient-rich medium for the use of cultivation, isolation and enumeration of a broad-spectrum of environmental and pathogenic yeasts and molds. The device can accept samples by direct plating or interface directly with standard methods for microbial testing of water samples using the Membrane Filter (MF) Technique1. The acidic pH of Malt Extract Agar allows for the optimal growth of molds and yeasts while restricting bacterial growth.

    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
    JSG Culture Media, Non-Selective And Non-Differential

    GMDN Terms

    Code Name
    58627 Malt extract agar culture medium IVD

    Identifiers

    Type ID
    Package B08813334
    Primary B08813330
    Package B08813332

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius