BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EURORealTime SARS-CoV-2

    DI: 04049016145660 · Model: MP 2606-0425 · EUROIMMUN Medizinische Labordiagnostika AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EURORealTime SARS-CoV-2
    Primary DI
    04049016145660
    Version / Model
    MP 2606-0425
    Company Name
    EUROIMMUN Medizinische Labordiagnostika AG
    Labeler DUNS
    322209263
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-04
    Public Version
    1
    Public Version Date
    2020-08-12
    Public Version Status
    New
    Public Device Record Key
    3343b08a-afe7-442f-a72e-3a9e3ecdbe4c

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    QJR Reagents, 2019-Novel Coronavirus Nucleic Acid

    GMDN Terms

    Code Name
    64747 SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 04049016145660