BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MYO CAL SET

    DI: 05055273204681 · Model: MY2456 · RANDOX LABORATORIES LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MYO CAL SET
    Primary DI
    05055273204681
    Version / Model
    MY2456
    Catalog Number
    MY2456
    Company Name
    RANDOX LABORATORIES LIMITED
    Labeler DUNS
    227530649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    3a8c2297-996e-4771-b9c3-842d20ce754e

    Device Description

    This product is intended for use in the calibration of Myoglobin immunoturbidimetric assays.

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DDR Myoglobin, Antigen, Antiserum, Control

    GMDN Terms

    Code Name
    41733 Myoglobin IVD, calibrator

    Identifiers

    Type ID
    Primary 05055273204681

    Customer Contacts

    Phone
    +442894451070
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K010700 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Reconstituted calibrators are stable for 30 days when stored at +2ºC and +8ºC in the absence of contamination. The calibrators may be frozen for up to 6 months at –20ºC.
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius