BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Myoglobin Enzyme Immunoassay Test Kit

    DI: 00083059070309 · Model: 7030 · BIOMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Myoglobin Enzyme Immunoassay Test Kit
    Primary DI
    00083059070309
    Version / Model
    7030
    Company Name
    BIOMERICA, INC.
    Labeler DUNS
    067647321
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-01
    Public Version
    1
    Public Version Date
    2020-07-09
    Public Version Status
    New
    Public Device Record Key
    7f2c42c4-b871-462d-8fc2-116e10630f13

    Device Description

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

    Device Characteristics

    Single Use
    No
    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
    DRR Amplifier And Signal Conditioner, Biopotential

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00083059070309

    Customer Contacts

    Phone
    +1 949 645 2111
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K022660 000