today we bring you information about a new set of immunophenotyping diagnostic reagents developed for you by the EXBIO company, which we have included in our offer at the turn of last and this year.
It is a 6-color TBNK cocktail (cat. no. ED7733) and two 4-color cocktails for determining T and B+NK cells (cat. no. ED7734 and ED7735).
These new combinations will replace our older reagents (ED7075, ED7045 and ED7074) later this spring. The main reason for the development of new reagents is the constant effort of our company EXBIO to bring modern and high-quality reagents to our customers, especially for the field of clinical diagnostics and, of course, also to fulfill all legal and regulatory requirements.
IFT reagents were developed here at EXBIO in the Product development department, led by Miroslav Benko. Specifically, Sr. Process Development Scientist Aleš Efenberk was in charge of the development. That’s why I asked both my colleagues to give us a brief overview of how the development took place, how these new reagents will hopefully benefit customers, and what are potential limitations of using these new diagnostics.
Miroslav Benko said: „With the introduction of strict requirements of the new IVD regulation EU2017/746, we knew, we had to do some updates in the ED7045, ED7074 and ED7075 KOMBITEST product range. We found so many product update possibilities, we had to develop a whole new product range while still providing the same product experience with emphasis on the highest product quality, performance and safety.„
Aleš Efenberk said: "Due to the introduction of the new Regulation (EU) 2017/746, it was necessary to revise the existing IVD products ED7045, ED7074 and ED7075 intended for TBNK screening and develop and register the new products in accordance with this regulation. Regulation (EU) 2017/746 makes much greater demands on registered products in all areas of their "life" cycle. Starting by precise planned development with clearly demonstrable results, production under strict supervision (GMP and GDocP is a matter of course) complying with the latest standards, quality control of each production step and all this with an emphasis on the reliability and safety of the given product. I am very happy that we have managed to develop modern product line at a top level in terms of quality, performance,reliability and safety."
More technical details and price quotations are available on request on our e-mail address email@example.com.
Developed according to ICCS/ESCCA consensus guidelines to detect PNH clones in erythrocytes, monocytes and neutrophils.
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