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510(k) Data Aggregation

    K Number
    K974613
    Device Name
    VIROTROL III
    Manufacturer
    BLACKHAWK BIOSYSTEMS, INC.
    Date Cleared
    1998-01-27

    (47 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    BLACKHAWK BIOSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VIROTROL III quality assurance reagent is a liquid unassayed human serum based quality control material intended for use with in vitro assay procedures for determination of immunoglobulin M antibodies to Hepatitis A Virus(HAV-IgM), immunoglobulin M antibodies to Hepatitis B core Antigen(HBc-IgM), Hepatitis B e Antigen(HBeAg) and total antibody to Hepatitis A Virus(anti-HAV). VIROTROL III reagents are intended to provide a means of estimating precision and have the potential for detecting systematic deviations from specific laboratory testing procedures.
    Device Description
    liquid unassayed human serum based quality control material
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    K Number
    K972129
    Device Name
    CHLAMYDIATROL AG
    Manufacturer
    BLACKHAWK BIOSYSTEMS, INC.
    Date Cleared
    1997-08-12

    (67 days)

    Product Code
    MJZ, MGM
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    BLACKHAWK BIOSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ChlamydiaTrol™ Ag is intended for use as an unassayed control reagent with in vitro diagnostic assay procedures for detection of Chlamydia trachomatis, including both chlamydial antigen (MOMP or LPS) and nucleic acid based methods of detection. ChlamydiaTrol Aq reagents are intended to provide a means of estimating precision and reproducibility, and have the potential for detecting systematic deviations from specific laboratory testing procedures. Use of ChlamydiaTrol Ag reagent will monitor assay functionality and not analytical sensitivity of the assay detection limits.
    Device Description
    ChlamydiaTrol Ag is a liquid quality control reagent classified under Multi Analyte Controls(assayed and unassayed). ChlamydiaTrol Ag reagent is prepared from Chlamydia trachomatis elementary bodies extracted from infected mouse L cells grown in culture. Optimally infected cells are harvested and disrupted by sonication, and cellular debris is removed by centrifugation. Chlamydia trachomatis elementary bodies used in the preparation of ChlamydiaTrol Ag reagent have been rendered noninfectious by treatment with gamma radiation. The reagent contains human serum albumin(HSA), preservatives and stabilizers.
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