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    K Number
    K030370
    Device Name
    REDLINE ANTHRAX ALERT TEST
    Manufacturer
    TETRACORE, INC
    Date Cleared
    2003-12-09

    (308 days)

    Product Code
    NPO
    Regulation Number
    866.3045
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    Product Code :

    NPO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tetracore RedLine Anthrax Alert™ Test is intended for the rapid, in vitro qualitative detection of Bacillus anthracis from non-hemolytic colonies obtained from sheep blood agar plates. The test is intended for use in clinical, public health, and hospital laboratories in conjunction with other markers and testing for the identification of Bacillus anthracis. The Tetracore RedLine Alert™Test is an immunochromatographic test intended for the rapid, in vitro qualitative presumptive identification of Bacillus anthracis from nonhemolytic Bacillus colonies cultured on sheep blood agar plates. The test is intended for use in clinical, public health, and hospital laboratories in conjunction with other markers and testing for the presumptive identification of Bacillus anthracis.
    Device Description
    The RedLine Anthrax Alert™ Test Cassette includes a reagent strip consisting of a combination of monoclonal and polyclonal antibodies that selectively detect the presence of Bacillus anthracis in aqueous specimens. The RedLine Anthrax Alert™ Test is supplied with single use test cassettes, Colony Isolation Buffer, and Positive Control reagent.
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