BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Anti-RSV ELISA (IgM)

    DI: 04049016028246 · Model: EI 2670-9601 M · EUROIMMUN Medizinische Labordiagnostika AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Anti-RSV ELISA (IgM)
    Primary DI
    04049016028246
    Version / Model
    EI 2670-9601 M
    Company Name
    EUROIMMUN Medizinische Labordiagnostika AG
    Labeler DUNS
    322209263
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2018-08-15
    Public Version Status
    Update
    Public Device Record Key
    f38199cf-6ba5-4731-98a5-5d0aafcd32dd
    Distribution End Date
    2018-08-13

    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
    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
    MCE Respiratory Syncytial Virus - Elisa

    GMDN Terms

    Code Name
    49508 Respiratory syncytial virus (RSV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 04049016028246

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius