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    FDA UDI In Commercial Distribution 🇺🇸 United States

    REAADS von Willebrand Factor Antigen Test Kit

    DI: 00855360006038 · Model: 034-001 · CORGENIX MEDICAL CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    REAADS von Willebrand Factor Antigen Test Kit
    Primary DI
    00855360006038
    Version / Model
    034-001
    Catalog Number
    034-001
    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
    3ad402d2-01c4-4755-9366-e9d5973bd444

    Device Description

    INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Von Willebrand Factor Antigen (VWF: Ag) in citrated human plasma. For In Vitro Diagnostic Use. SUMMARY THE TEST Von Willebrand Factor Antigen (VWF:Ag or Factor VIII-related protein) is a plasma protein found in circulation combined by non-covalent interactions with Factor VIII (FVIII:C), a pro-coagulant protein also known as the anti-hemophilic factor. These two proteins show distinct biochemical and functional properties as well as different antigenic determinants; their plasma levels may vary independently of each other. Deficiency of FVIII causes classic hemophilia while deficiency of VWF causes Von Willebrand disease. VWF:Ag plays a very important role in hemostasis. The prevalence of Von Willebrand disease has been estimated to be 1-3% of the general population. Approximately 80% of Von Willebrand disease patients have a type I deficiency. The laboratory diagnosis of Von Willebrand disease may require both quantitative and qualitative (functional) determinations. PRINCIPLE OF THE TEST REAADS VWF:Ag assay is a sandwich ELISA. A capture antibody specific for human VWF is coated to 96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any available VWF:Ag to bind to the anti-human VWF antibody on the microwell surface. The plates are washed to remove unbound proteins and other plasma molecules. Bound VWF:Ag is quantitated using horseradish peroxidase (HRP) conjugated anti-human VWF detection antibody. Following incubation, unbound conjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in optical density (O.D.) units with a spectrophotometer at 450nm. Patient VWF:Ag in relative percent concentration is determined against a curve made from the reference plasma provided with the kit. 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
    GGP Test, Qualitative And Quantitative Factor Deficiency

    GMDN Terms

    Code Name
    56026 Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00855360006038

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K972005 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius