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510(k) Data Aggregation

    K Number
    K964015
    Device Name
    INDICARD TEST
    Manufacturer
    LITMUS CONCEPTS, INC.
    Date Cleared
    1997-06-19

    (255 days)

    Product Code
    MJM
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    MJM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Indicard™ test is an enzyme activity test for use in the detection of Gardnerella vaginalis Proline IminoPeptidase (PIP) activity in vaginal fluid specimens from patients suspected of having vaginosis. The Indicard™ test is indicated for professional use only and may be used at point of care. It is not intended for home use.
    Device Description
    The Indicard™ test is an enzyme activity test.
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