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NEW IN CHINA: ABD-LYS IS NOW SFDA REGISTERED
The registration certificate for medical device (according to Directive 98/79/EC) certifies that our product ABD Lys has been inspected by the S.F.D.A.’s office (State Food and Drug Administration) and is permitted to register on the Chinese market. This certificate n° 2012 3400229 is valid for 4 years (until January 30th, 2016).
The kit of ABD-Lys is in vitro diagnostic Medical Device (IVDMD) for professional use. It is used for ABO-D(RH1) grouping of human red blood cells. It enables determination of the presence of erythrocytic antigens A (ABO1), B (ABO2) and D (RH1) on the surface of the human red blood cells.Intended use of the kit ABD-Lys is to determine the human blood group. The kit is composed of Anti A, Anti B, Anti D IgM and Negative Control. The principle of the reaction is hema-agglutination.
Marketing / Performances of ABD-Lys:
The ABD-Lys has been registered in several countries and zone all over the world, for example, in European Union, in India, in Indonesia, in Philippines, in South Korea, in Thailand, in Turkey, in Russia, in Brazil etc. The sales of ABD-Lys have covered 5 continents for 20 countries.
There were 347 040 samples that have been tested with ABD-Lys in 2009 all over the world, and about 810 560 samples in 2010. The accuracy of tested results on using ABD-Lys is 100%.
In Abu Dhabi blood bank November 2010, forward and reverse ABO/Rh typing were performed on 1 236 donors samples collected on EDTA using the EM Technology method on QWALYS, the samples were tested on Techno TwinStation, then on QWALYS within 24 hours. Among 1 236 samples, a correlation of 100% was observed on ABO RH1 direct grouping and reverse typing.
In Escort Heart Institute February 2010, 890 samples of on ABO RH1 direct grouping and reverse typing were performed on QWALYS, the blood samples have been tested within 48 hours, no hemolysis or clot has been visible in the samples. All the grouping and reverse typing were 100% concordance with regards to reference techniques and also in ID Gel card.
For more information, please contact our Chinese distributor: