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510(k) Data Aggregation

    K Number
    K964874
    Device Name
    HSV-1 ANTIGEN CONTROL SLIDES
    Manufacturer
    VIRAL ANTIGENS, INC.
    Date Cleared
    1997-07-01

    (208 days)

    Product Code
    GQN
    Regulation Number
    866.3305
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIRAL ANTIGENS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HSV-1 Antigen Control Slides are quality control materials used to confirm the accuracy of staining reagents used in cell culture confirmatory assays for the detection of HSV-1. Each individual slide contains two wells of fixed cells, one HSV-1 infected well and one uninfected well. The two wells of cells on the HSV-1 Antigen Control Slide are stained concomitantly with the cells inoculated with patient sample providing both a positive and negative control for the staining reagents and procedure. Lack of staining of the positive well indicates a failure of one or more components of the staining reagent.
    Device Description
    Each individual slide contains two wells of fixed cells, one HSV-1 infected well and one uninfected well.
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    K Number
    K971101
    Device Name
    HSV-2 ANTIGEN CONTROL SLIDES
    Manufacturer
    VIRAL ANTIGENS, INC.
    Date Cleared
    1997-07-01

    (97 days)

    Product Code
    GQN
    Regulation Number
    866.3305
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIRAL ANTIGENS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HSV-2 Antigen Control Slides are quality control materials used to confirm the accuracy of staining reagents used in cell culture confirmatory assays for the detection of HSV-2. Each individual slide contains two wells of fixed cells, one HSV-2 infected well and one uninfected well. The two wells of cells on the HSV-2 Antigen Control Slide are stained concomitantly with the cells inoculated with patient sample providing both a positive and negative control for the staining reagents and procedure. Lack of staining of the positive well indicates a failure of one or more components of the staining reagent.
    Device Description
    Each individual slide contains two wells of fixed cells, one HSV-2 infected well and one uninfected well.
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    K Number
    K964870
    Device Name
    RSV ANTIGEN CONTROL SLIDES
    Manufacturer
    VIRAL ANTIGENS, INC.
    Date Cleared
    1997-03-18

    (103 days)

    Product Code
    GQG
    Regulation Number
    866.3480
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIRAL ANTIGENS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K964872
    Device Name
    VZV ANTIGEN CONTROL SLIDES
    Manufacturer
    VIRAL ANTIGENS, INC.
    Date Cleared
    1997-03-18

    (103 days)

    Product Code
    GQW
    Regulation Number
    866.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIRAL ANTIGENS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K964875
    Device Name
    CMV ANTIGEN CONTROL SLIDES
    Manufacturer
    VIRAL ANTIGENS, INC.
    Date Cleared
    1997-03-18

    (103 days)

    Product Code
    GQH
    Regulation Number
    866.3175
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIRAL ANTIGENS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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