BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Anti-AtherOxTM IgG Test Kit (OxLDL-B2GPI IgG Antibody)

    DI: 00855360006236 · Model: 11854 · CORGENIX MEDICAL CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Anti-AtherOxTM IgG Test Kit (OxLDL-B2GPI IgG Antibody)
    Primary DI
    00855360006236
    Version / Model
    11854
    Catalog Number
    11854
    Company Name
    CORGENIX MEDICAL CORPORATION
    Labeler DUNS
    619834542
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-08
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    2611afe2-115f-40d5-8020-415fffb22dc8
    Distribution End Date
    2017-02-21

    Device Description

    INTENDED USE An enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with β2-glycoprotein I (β2GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). For In Vitro Diagnostic Use Only. SUMMARY AND EXPLANATION OF THE ASSAY The antiphospholipid syndrome (APS) is one of the most common causes of acquired hypercoagulability (thrombophilia) It is frequently diagnosed in the context of a systemic autoimmune disorder such as SLE (secondary APS), however, it may also occur in the absence of an obvious underlying disease (primary APS). Oxidative stress and oxLDL formation are common in patients with SLE and APS suggesting an important relationship between lipid peroxidation and clotting activation (hypercoagulability). The presence of circulating IgG anti-oxLDL-β2GPI antibodies seem to be etiologically important. PRINCIPLE OF THE TEST This test is an indirect ELISA detecting IgG anti-oxLDL-β2GPI antibodies. Diluted serum samples, calibrator(s), and controls are incubated in microwells coated with the oxLDL- β2GPI complex. After the removal of unbound serum proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added. Following another wash, 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 IgG anti-oxLDL-β2GPI antibody. Results are obtained by reading the OD of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-oxLDL-β2GPI antibody concentration expressed in G Units. A log-log regression analysis is performed with calibrator values plotted against calibrator mean O.D.’s. Controls and patient results are determined from the calibration curve. 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
    MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

    GMDN Terms

    Code Name
    62226 Oxidized low density lipoprotein-B2-glycoprotein I (OxLDL-B2GPI) complex antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00855360006236

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K072032 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius