BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MLH-1

    DI: 00847627037428 · Model: NPAI220T40 · BIOCARE MEDICAL LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    MLH-1
    Primary DI
    00847627037428
    Version / Model
    NPAI220T40
    Company Name
    BIOCARE MEDICAL LLC
    Labeler DUNS
    806617825
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-06-20
    Public Version
    1
    Public Version Date
    2025-06-30
    Public Version Status
    New
    Public Device Record Key
    099b65bf-291a-44dc-a87f-e0d58ddf8b11

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    NJT Immunohistochemistry Reagents And Kits

    GMDN Terms

    Code Name
    57423 MLH1 antigen IVD, antibody

    Identifiers

    Type ID
    Primary 00847627037428

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius