BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mycoplasma genitalium macrolide resistance IVT A2058G Control

    DI: 15430001412090 · Model: 1 · Diagenode
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mycoplasma genitalium macrolide resistance IVT A2058G Control
    Primary DI
    15430001412090
    Version / Model
    1
    Catalog Number
    PRD-06110
    Company Name
    Diagenode
    Labeler DUNS
    373050462
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-15
    Public Version
    1
    Public Version Date
    2021-03-23
    Public Version Status
    New
    Public Device Record Key
    034dd274-8978-41b4-80f3-928839ff073b

    Device Description

    In vitro transcript of Mycoplasma genitalium 23S RNA including A2058G mutation

    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    47323 Mycoplasma genitalium nucleic acid IVD, control

    Identifiers

    Type ID
    Primary 15430001412090