BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    illumigene Mycoplasma

    DI: 00840733101175 · Model: 280550 · MERIDIAN BIOSCIENCE, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    illumigene Mycoplasma
    Primary DI
    00840733101175
    Version / Model
    280550
    Catalog Number
    280550
    Company Name
    MERIDIAN BIOSCIENCE, INC.
    Labeler DUNS
    092815364
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    4
    Public Version Date
    2020-06-29
    Public Version Status
    Update
    Public Device Record Key
    a746384f-b460-4407-af2d-a15483569362
    Distribution End Date
    2019-01-31

    Device Description

    "The illumigene Mycoplasma DNA amplification assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat and nasopharyngeal swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The illumigene Mycoplasma assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome. Results from the illumigene Mycoplasma DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management.

    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
    OOI Real Time Nucleic Acid Amplification System
    OZX Mycoplasma Pneumoniae Dna Assay System

    GMDN Terms

    Code Name
    47328 Mycoplasma pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00840733101175

    Customer Contacts

    Phone
    513-271-3700
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K123423 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius