BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IMMUNOFLOW™ Mycoplasma pneumoniae IgM Test

    DI: 00613745000060 · Model: 800-7005 · GenBio
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    IMMUNOFLOW™ Mycoplasma pneumoniae IgM Test
    Primary DI
    00613745000060
    Version / Model
    800-7005
    Catalog Number
    7005
    Company Name
    GenBio
    Labeler DUNS
    940425333
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-31
    Public Version
    2
    Public Version Date
    2026-04-20
    Public Version Status
    Update
    Public Device Record Key
    2909c9ea-2b65-4e53-82fb-18e07e7db815

    Device Description

    ImmunoFLOW Mycoplasma pneumoniae IgM Test detects human IgM to the complement-fixing antigen and is intended as an aid in the diagnosis of infection.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

    GMDN Terms

    Code Name
    51202 Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00613745000060

    Customer Contacts

    Phone
    858-592-9300
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 25 tests

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius