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    FDA UDI In Commercial Distribution 🇺🇸 United States

    REAADS Anti-dsDNA Test Kit

    DI: 00855360006205 · Model: 13086 · CORGENIX MEDICAL CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    REAADS Anti-dsDNA Test Kit
    Primary DI
    00855360006205
    Version / Model
    13086
    Catalog Number
    13086
    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
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    5341db7b-76f5-434c-a313-c2d85619d565

    Device Description

    INTENDED USE Anti-dsDNA is an indirect solid phase enzyme immunoassay (ELISA) for the quantitative measurement of IgG class autoantibodies against double-stranded DNA in human serum or plasma. The assay is intended as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE). For In Vitro Diagnostic Use. SUMMARY OF THE TEST Autoimmune diseases are characterized by the occurence of antibodies against one’s own antigenic structures, also known as autoantibodies. Presence of autoantibodies to native desoxyribonucleic acids (n-DNA, dsDNA, double-stranded DNA) is typical for the clinical picture of SLE. Antibodies against dsDNA belong to the group of Anti Nuclear Antibodies (ANA), which are directed against various structures of the nucleus of the cell. They appear in a variety of rheumatoid diseases. Antibodies to dsDNA are found during the active phases of SLE. Diagnostic sensitivity of the anti-dsDNA determination in cases of SLE is approximately 91 % combined with a diagnostic specificity of nearly 96 percent. SLE like diseases are caused by some drugs. For differential diagnosis of drug-induced SLE the determination of anti-dsDNA is a valuable diagnostic tool. PRINCIPLE OF THE TEST Human recombinant double-stranded DNA (dsDNA) is bound to microwells. Antibodies to this antigen bind to the respective antigen. Washing of the microwells removes unspecific serum/plasma components. Horseradish peroxidase (HRP) conjugated anti-human IgG immunologically detects the bound patient antibodies forming a conjugate/antibody/antigen complex. Washing of the microwells removes unbound conjugate. An enzyme substrate in the presence of bound conjugate hydrolyzes to form a blue color. The addition of an acid stops the reaction forming a yellow color in the test well which is measured photometrically at 450 nm. The amount of color is directly proportional to the concentration of IgG antibodies present in the original sample. Refer to Product 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
    LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control

    GMDN Terms

    Code Name
    54902 Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00855360006205

    Customer Contacts

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

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius