In Vitro Diagnostic Directive(IVD) 98/79/EC Annex II

Official Journal of the European Communities L 331 , 07/12/1998 p. 0001 - 0037

ANNEX II : LIST OF DEVICES REFERRED TO IN ARTICLE 9(2) (3)

List A
Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell, reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D.

List B
Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: anti-Duffy and anti-Kidd, reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies, reagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosis, reagents and reagent products, including related calibrators and control materials, for diagnosing the following hereditary disease: phenylketonuria, reagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydia, reagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, B, reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA, reagents and reagent products, including related calibrators, control materials and software, designed specifically for evaluating the risk of trisomy 21, the following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar.

Last updated Dec 28, 2008

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