Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K161951
    Device Name
    KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
    Manufacturer
    KRONUS, INC.
    Date Cleared
    2016-07-22

    (7 days)

    Product Code
    PNI
    Regulation Number
    866.5665
    Why did this record match?
    Product Code :

    PNI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay is for the semi-quantitative determination of autoantibodies to Aquaporin-4 in human serum. The KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay may be useful as an aid in the diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD). The KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay is not to be used in conjunction with other clinical, laboratory, and radiological (e.g. MRI) findings.
    Device Description
    Not Found
    Ask a Question
    K Number
    DEN150030
    Device Name
    KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
    Manufacturer
    KRONUS, INC.
    Date Cleared
    2016-04-25

    (298 days)

    Product Code
    PNI
    Regulation Number
    866.5665
    Why did this record match?
    Product Code :

    PNI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay is for the semiquantitative determination of autoantibodies to Aquaporin-4 in human serum. The KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay may be useful as an aid in the diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD). The KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay is not to be used alone and is to be used in conjunction with other clinical, laboratory, and radiological (e.g., MRI) findings.
    Device Description
    The KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay consists of ELISA strip wells coated with human recombinant AQP4 protein (amino acid position: 23-323) (96 wells in total) and supplied as 12 strips of 8 wells in a frame and sealed in a foil pouch with desiccant; ready-to-use 5 levels of calibrators (1.5, 5, 20, 40, and 80 U/mL), 5 x 0.7 mL; a ready-to-use positive (2 x . 7 mL) and a negative control serum (1 x 0.7 mL); AQP4-Biotin (lyophilized), 3 x 1.5 mL (reconstituted); ready-to-use reconstitution buffer for AQP4-Biotin, 1 x 10 mL; Streptavidin Peroxidase (SA-POD dilute before use) 1 x 0.8 mL; ready-to-use diluent for SA-POD, 1 x 15 mL; ready-to-use peroxidase substrate (TMB), 1 x 15 mL; concentrated wash solution (dilute 1:10 with deionized water before use), 1 x 120 mL and ready-to-use stop solution, 1 x 14 mL.
    Ask a Question

    Page 1 of 1