BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ANCA Screen IgG ELISA

    DI: 00840239027771 · Model: EIA-2777 · DRG International Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ANCA Screen IgG ELISA
    Primary DI
    00840239027771
    Version / Model
    EIA-2777
    Catalog Number
    EIA-2777
    Company Name
    DRG International Inc
    Labeler DUNS
    075150847
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-23
    Public Version
    1
    Public Version Date
    2023-08-31
    Public Version Status
    New
    Public Device Record Key
    131dd1d5-849c-407a-9265-2c3be4ab0ff9

    Device Description

    The ANCA Screen ELISA test system is intended for the qualitative detection of anti-Myeloperoxidase and/or anti-Proteinase-3 IgG antibody in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of anti-neutrophil cytoplasmic antibodies (ANCA). MPO and/or PR-3 may be associated with autoimmune disorders such as Wegener’s Granulamatosis, ICGN, MPA and PRS.

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

    GMDN Terms

    Code Name
    55062 Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00840239027771

    Customer Contacts

    Phone
    9735647555
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K964448 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius