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510(k) Data Aggregation

    K Number
    K181473
    Device Name
    DENV Detect NS1 ELISA
    Manufacturer
    InBios International, Inc.
    Date Cleared
    2018-08-27

    (84 days)

    Product Code
    QCU
    Regulation Number
    866.3945
    Why did this record match?
    Product Code :

    QCU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DENV Detect™ NS1 ELISA is for the early detection of Dengue virus (DENV) NS1 antigen in human serum. This test is for the presumptive clinical laboratory diagnosis of Dengue virus infection. This assay is intended for use in patients with clinical symptoms consistent with either dengue hemorrhagic fever. Samples collected from patients within seven (7) days after the onset of clinical symptoms should be evaluated with this assay (day 0 - day 7). Negative results obtained with this test do not preclude the diagnosis of dengue and should not be used as the sole basis for treatment or other patient management decision. This assay is not FDA cleared or approved for testing blood or plasma donors.
    Device Description
    Not Found
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