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    K Number
    K191184
    Device Name
    ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
    Manufacturer
    SSI Diagnostica A/S
    Date Cleared
    2020-03-05

    (307 days)

    Product Code
    MJH, GTZ
    Regulation Number
    866.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SSI Diagnostica A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test is an in vitro, rapid, lateral flow test, also known as a lateral flow immunochromatographic assay, intended for the qualitative detection of Streptococus pneumoniae and Legionella pneumophila antigens in urine specimens with symptoms of pneumonia. The assay is intended to aid in diagnosis of S. pneumoniae and L. pneumophila serogroup 1 infections. The assay is further intended to aid in the diagnosis of S. pneumoniae infection of S. pneumoniae antigen in cerebrospinal fluid (CSF). Results from the ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test should be interpreted in conjunction with the patient's clinical evaluation and other diagnostic methods.
    Device Description
    ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test is a rapid lateral flow test for qualitative detection of S. pneumoniae in human urine and CSF samples and L. pneumophila (primarily serogroup 1) antigens in human urine samples. The test is effective in presumptive diagnosis of pneumococcal pneumonia caused by S. pneumoniae or Legionella pneumonia (Legionnaires' disease) caused by L. pneumophila, in conjunction with culture and other methods. Correct and early treatment is vital for the prognosis of both diseases and therefore quick methods to confirm both diseases in the initial phase are very important in order to initiate the proper antibiotic treatment as soon as possible.
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