BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Diamedix

    DI: 00817273020181 · Model: 720-350 · DIAMEDIX CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Diamedix
    Primary DI
    00817273020181
    Version / Model
    720-350
    Company Name
    DIAMEDIX CORPORATION
    Labeler DUNS
    151765328
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    4
    Public Version Date
    2021-08-09
    Public Version Status
    Update
    Public Device Record Key
    282a349c-6718-4c86-8529-89dd92d25404

    Device Description

    "720-350 HSV 1&2 IgM Test Kit"

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LCG Intestinal Splinting Tubes

    GMDN Terms

    Code Name
    52036 Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00817273020181

    Customer Contacts

    Phone
    305-324-2300
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K002262 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius