BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Simplexa™ VZV Direct

    DI: 20816101025774 · Model: MOL3650 · DIASORIN MOLECULAR LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Simplexa™ VZV Direct
    Primary DI
    20816101025774
    Version / Model
    MOL3650
    Company Name
    DIASORIN MOLECULAR LLC
    Labeler DUNS
    080271715
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-19
    Public Version
    1
    Public Version Date
    2019-06-27
    Public Version Status
    New
    Public Device Record Key
    d213d7b0-4aff-4371-94c0-249f38e04fd6

    Device Characteristics

    Single Use
    No
    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
    PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

    GMDN Terms

    Code Name
    47291 Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 20816101025774