BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ihcDirect® Mart-1 Ab Conjugate 10mL

    DI: 00850000596993 · Model: H31009-R010 · NOVODIAX, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ihcDirect® Mart-1 Ab Conjugate 10mL
    Primary DI
    00850000596993
    Version / Model
    H31009-R010
    Catalog Number
    K46009-010
    Company Name
    NOVODIAX, INC.
    Labeler DUNS
    965326957
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-08-20
    Public Version
    1
    Public Version Date
    2021-08-30
    Public Version Status
    New
    Public Device Record Key
    930fd0c4-ce39-46de-b39a-804885c8a02a

    Device Characteristics

    Single Use
    No
    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
    Yes
    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
    57392 Melan-A/MART-1 peptide IVD, kit, enzyme immunohistochemistry

    Identifiers

    Type ID
    Primary 00850000596993

    Customer Contacts

    Phone
    5103423043
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Total Volume 10 Milliliter

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    21 – 30 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius