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510(k) Data Aggregation

    K Number
    K150144
    Device Name
    VisuCon-F Low Fibrinogen Control Plasma
    Manufacturer
    AFFINITY BIOLOGICALS INC.
    Date Cleared
    2016-03-06

    (409 days)

    Product Code
    GGN
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    AFFINITY BIOLOGICALS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended "For In Vitro Diagnostic Use".
    Device Description
    The VisuCon-F Low Fibrinogen Control plasma is a pool of de-fibrinated citrated human plasma buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
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    K Number
    K110432
    Device Name
    VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN
    Manufacturer
    AFFINITY BIOLOGICALS INC.
    Date Cleared
    2011-10-20

    (247 days)

    Product Code
    GGN
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    AFFINITY BIOLOGICALS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VisuCon-F Frozen Coag Screen N plasma is an assayed normal control plasma intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated partial thromboplastin time (APTT) and fibrinogen, in the normal range. The VisuCon-F Frozen Coag Screen N plasma may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents. The VisuCon-F Frozen Coag Screen ABN plasma is an assayed abnormal control plasma intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated partial thromboplastin time (APTT), in the mid-level abnormal range. The VisuCon-F Frozen Coag Screen ABN plasma may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents.
    Device Description
    The VisuCon-F Frozen Coag Screen N is a pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen. The VisuCon-F Frozen Coag Screen ABN is a pool of normal citrated human plasma collected from a minimum of 20 donors, diluted to defined concentrations, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
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    K Number
    K091284
    Device Name
    VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA
    Manufacturer
    AFFINITY BIOLOGICALS INC.
    Date Cleared
    2009-10-28

    (180 days)

    Product Code
    GGN, JIX
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    AFFINITY BIOLOGICALS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VisuCal-F Frozen Calibrator plasma is intended for use in the calibration of coaqulation and fibrinolysis assays including the following: fibrinogen (Clauss Method), coaqulation factors II, V, VII, VIII, IX, X, XI, XII, antithrombin activity, alpha-2-antiplasmin, plasminogen, Protein C activity and antigen, Protein S activity and total antigen and von Willebrand factor antigen and Ristocetin Cofactor. The VisuCon-F Frozen Abnormal Control plasma is intended for use in the quality control of coagulation assays in the borderline pathological range for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, IX, X, XI, XII, antithrombin activity, Protein C activity and Protein S activity. The VisuCon-F Frozen Normal Control plasma is intended for use in the quality control of coagulation assays in the normal range for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, VIII, IX, X, XI, XII, antithrombin activity, Protein C activity and Protein S activity.
    Device Description
    The VisuCal-F Frozen Calibrator Plasma is a pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen. The VisuCon-F Frozen Normal Control Plasma is a pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen. The VisuCon-F Frozen Abnormal Control Plasma is a pool of normal citrated human plasma collected from a minimum of 20 donors, diluted to defined concentrations, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
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    K Number
    K052825
    Device Name
    VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG
    Manufacturer
    AFFINITY BIOLOGICALS INC.
    Date Cleared
    2006-01-20

    (107 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    AFFINITY BIOLOGICALS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VisuLize™ Factor VIII Antigen Kit is an Enzyme Immunoassay for the quantitative determination of Factor VIII Antigen in human plasma samples and Factor VIII concentrates using the double antibody enzyme linked immuno-sorbent assay (ELISA)
    Device Description
    The VisuLize™ Factor VIII Antigen kit is a sandwich enzyme-linked immuno-sorbent assay (ELISA) using a polyclonal antibody coated 96-microwell format. Plasma samples are diluted and applied to the pre-coated wells. After washing away unbound proteins, a horseradish peroxidase (HRP) labelled polyclonal antibody is applied to detect the captured Factor VIII. A chromogenic substrate (TMB) is added to allow for color development. The color formed is measured spectrophotometrically at 450 nm, with the absorbance being directly proportional to the concentration of Factor VIII that was in the sample.
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    K Number
    K051054
    Device Name
    VISULIZE FACTOR IX ANTIGEN KIT
    Manufacturer
    AFFINITY BIOLOGICALS INC.
    Date Cleared
    2005-06-29

    (64 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    AFFINITY BIOLOGICALS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VisuLize™ Factor IX Antigen Kit is intended for use as an in vitro diagnostic assay for the quantitative determination of Factor IX antigen in human plasma samples and Factor IX concentrates using the double antibody enzyme linked immuno-sorbent assay (ELISA).
    Device Description
    The VisuLize™ Factor IX Antigen kit is a sandwich enzyme-linked immuno-sorbent assay (ELISA) using a polyclonal antibody coated 96-microwell format. Plasma samples are diluted and applied to the pre-coated wells. After washing away unbound proteins, a horseradish peroxidase (HRP) labelled polyclonal antibody is applied to detect the captured Factor IX. A chromogenic substrate (TMB containing H2O2) is added to allow for color development. The color formed is measured spectrophotometrically at 450 nm, with the absorbance being directly proportional to the concentration of Factor IX that was in the sample.
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