IVD Annex II: List of Devices

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 Nov 10, 2008

View all Publications