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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Corgenix Anti-Cardiolipin IgM Semi-Quantitative Test Kit (192 Well)

    DI: 00855360006076 · Model: 13529 · CORGENIX MEDICAL CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Corgenix Anti-Cardiolipin IgM Semi-Quantitative Test Kit (192 Well)
    Primary DI
    00855360006076
    Version / Model
    13529
    Catalog Number
    13529
    Company Name
    CORGENIX MEDICAL CORPORATION
    Labeler DUNS
    619834542
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-14
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    dcfc0817-4892-498a-aac3-71f5b8a5157c

    Device Description

    INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use. SUMMARY AND EXPLANATION OF THE TEST Anti-phospholipid antibodies are autoantibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After removal of unbound serum proteins by washing, antibodies specific for human IgM labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of aCL antibodies. Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgM aCL concentrations expressed in MPL units. One MPL unit is equivalent to 1 μg/mL of an affinity purified standard IgM sample. Control and patient results are determined from the calibration curve. Refer to Package Insert.

    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
    MID System, Test, Anticardiolipin Immunological

    GMDN Terms

    Code Name
    54870 Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00855360006076

    Customer Contacts

    Phone
    1-800-729-5661
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K032868 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius