BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Myoglobin ELISA

    DI: 04048474039559 · Model: EIA-3955 · DRG Instruments Gesellschaft mit beschränkter Haftung
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Myoglobin ELISA
    Primary DI
    04048474039559
    Version / Model
    EIA-3955
    Catalog Number
    EIA-3955
    Company Name
    DRG Instruments Gesellschaft mit beschränkter Haftung
    Labeler DUNS
    317134468
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-31
    Public Version
    2
    Public Version Date
    2024-08-01
    Public Version Status
    Update
    Public Device Record Key
    7c5b8510-0870-4c9f-bbd4-059eb068f057
    Distribution End Date
    2024-06-19

    Device Description

    The Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum.

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DRR Amplifier And Signal Conditioner, Biopotential

    GMDN Terms

    Code Name
    53953 Myoglobin IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 04048474039559

    Customer Contacts

    Phone
    973-564-7555
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius