BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Anti-ds-DNA-G ELISA

    DI: B24235DSGHUE010 · Model: 35-DSGHU-E01 · AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Anti-ds-DNA-G ELISA
    Primary DI
    B24235DSGHUE010
    Version / Model
    35-DSGHU-E01
    Catalog Number
    35-DSGHU-E01
    Company Name
    AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
    Labeler DUNS
    784143778
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-18
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    9d2a05d0-955f-4936-8279-7e29e5cf79f6

    Device Description

    Anti-ds-DNA-G ELISA is a solid phase enzyme immunoassay with human recombinant double-stranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum. Anti-dsDNA antibodies mainly recognize the phosphat units of the DNA, thus these autoantibodies also bind single stranded DNA (ssDNA). To ensure correct quantitation of anti-dsDNA antibodies the used antigen has been proven to be free of contamination with ssDNA. The assay is a tool in the differential diagnosis of systemic lupus erythematosus (SLE).

    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
    LSW Anti-Dna Antibody, Antigen And Control

    GMDN Terms

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

    Identifiers

    Type ID
    Primary B24235DSGHUE010

    Customer Contacts

    Phone
    800.592.5726
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K041628 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius