Surveillance audit for assessment of compliance with the requirement of European Directive 98/79/EC for In Vitro diagnostics medical devices was conducted on 14th, April, 2015 in Alkor Bio Company Ltd. Two kits - ToxoplasmaEIA IgG kit for qualitative and quantitative detection of immunoglobulins G to Toxoplasma gondii and ToxoplasmaEIA IgG Avidity kit for detection of immunoglobulins G avidity to Toxoplasma gondii in the human blood serum and plasma were assessed. As these CE-marked kits are included into the List B, Annex II of European Directive 98/79/EC, the Notified Body participation is required for their assessment. Lloyd`s Register LRQA, Great Britain, was involved in the audit as Notified Body. The audit results confirmed the compliance with all EC requirements established for such kits.
