BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QUANTA Lite® dsDNA SC ELISA

    DI: 08426950544111 · Model: 704650 · INOVA DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    QUANTA Lite® dsDNA SC ELISA
    Primary DI
    08426950544111
    Version / Model
    704650
    Company Name
    INOVA DIAGNOSTICS, INC.
    Labeler DUNS
    188354831
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-31
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    1e7ebccf-d474-483f-8265-00209cb74d0f

    Device Description

    1.Instruction leaflet: Giving full assay details. 2. QC Certificate: Indicating the expected performance of the batch. 3. dsDNA SC Coated Wells: 12 breakapart 8 well strips coated with calf thymus dsDNA antigen. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches. 4. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use. 5. dsDNA SC Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-dsDNA autoantibody: 1000, 333, 111, 37, 12.3 IU/mL. Ready to use. 6. dsDNA SC Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use. 7. Type III Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored yellow, ready to use. 8. HRP Wash Concentrate (40X): 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells. 9.dsDNA SC Single Stranded Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use. 10. HRP dsDNA SC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use. 11. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use. 12. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use.

    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 08426950544111

    Customer Contacts

    Phone
    1-800-545-9495
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K993727 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius