BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mycoplasma genitalium macrolide resistance primers

    DI: 15430001412069 · 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 primers
    Primary DI
    15430001412069
    Version / Model
    1
    Catalog Number
    PRD-061107
    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
    198426a7-0b90-4170-a6d0-629ff6cc0e93

    Device Description

    Oligonucleotides designed to detect the mutations associated to macrolide resistance on 23S RNA (A2058C, A2058G, A2058T, A2058C and A2059G)

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MVU Reagents, Specific, Analyte

    GMDN Terms

    Code Name
    47324 Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 15430001412069