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        IVD產品CE認證公告機構
         National Standards Authority of Ireland (NSAI)
        1 Swift Square, Northwood, Santry
        Dublin 9
        Ireland
        0050 Devices for self-testing EC declaration of
        conformity
        Full quality assurance
        system
        Production quality
        assurance
        Annex III
        Annex IV
        Annex VII
        Products referred in Annex II, list A
        Products referred in Annex II, list B
        Full quality assurance
        system
        Production quality
        assurance
        Annex IV
        Annex VII
        BSI
        Kitemark House, Maylands Avenue,
        Hemel Hempstead, Hertfordshire HP2 4SQ
        United Kingdom
        0086 *IVD 0100 - Reagents and reagent products, including
        related calibrators and control materials, for determining
        the following blood groups
        - *IVD 0101 - ABO system
        - *IVD 0102 - Rhesus (C, c, D, E, e)
        - *IVD 0103 - Anti-Kell
        *IVD 0200 - Reagents and reagent products, including
        related calibrators and control materials, for the
        detection, confirmation and quantification in human
        specimens of markers of
        - *IVD 0201 - HIV infection (HIV 1 and 2)
        - *IVD 0202 - HTLV I and II
        - *IVD 0203 - Hepatitis B, C and D
        Full quality assurance
        system
        EC type-examination
        Production quality
        assurance
        Annex IV
        Annex V
        Annex VII
        *IVD 0300 - Reagents, reagent products and devices for
        self-diagnosis, including related calibrators and control
        materials, for determining, detection, quantification,
        diagnosing, evaluating
        Full quality assurance
        system
        EC type-examination
        EC verification
        Annex IV
        Annex V
        Annex VI
        Annex VII
        Creation Date : 21/01/2011
        LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 98/79/EC In vitro diagnostic medical devices
        Name and address of the notified
        bodies
        ID Responsible for the following products
        /Horizontal technical competence
        Responsible for the
        following procedures
        or modules
        Annexes or
        articles of the
        directives
        Limitations (English only)
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