BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Magnesium Reagent Set

    DI: 00812137012012 · Model: R1 x 2 x 120mL, R2 x 2 x 120mL · CLINICAL DIAGNOSTIC SOLUTIONS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    4

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    Basic Information

    Brand Name
    Magnesium Reagent Set
    Primary DI
    00812137012012
    Version / Model
    R1 x 2 x 120mL, R2 x 2 x 120mL
    Catalog Number
    501-414
    Company Name
    CLINICAL DIAGNOSTIC SOLUTIONS, INC.
    Labeler DUNS
    048144997
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    4
    Record Status
    Published
    Publish Date
    2016-10-12
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    258bd775-4e11-41e8-980f-1e1a2375cc3f

    Device Description

    For the quantitative determination of magnesium in serum. For in vitro diagnostic use only. Magnesium in the body is found primarily in bone with some in soft tissue, blood cells, and serum. Decreased levels have been observed in cases of diabetes, alcoholism, diuretics, hyperthyroidism, hypothyroidism, malabsorption, hyperalimenation, myocardial infarction, congestive heart failure and liver cirrhosis. Increased serum magnesium levels have been found in renal failure, diabetic acidosis, Addison’s disease, and vitamin D intoxication.

    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
    Yes
    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
    JGJ Photometric Method, Magnesium

    GMDN Terms

    Code Name
    52883 Magnesium (Mg2+) IVD, reagent

    Identifiers

    Type ID
    Primary 00812137012012
    Unit of Use 00812137012364

    Customer Contacts

    Phone
    8004533328
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 25 Degrees Celsius