chemagen´s First CE Certified Product

24 Feb 2009
Samantha Rosoman
Campaign Coordinator

chemagen Biopolymer-Technologie AG, Germany, announces its first CE certified Plasma Kit, which facilitates an automated preparation of DNA/RNA from 2 ml plasma samples. 1 - 24 samples can be processed in parallel using the chemagic Separation Module I and within 60 minutes the DNA/RNA is then ready to use for your in vitro Diagnostic applications.

The chemagic Plasma D2.0 Kit is now CE certified in compliance with EU IVD Directive 98/79/EC*. This mark particularly helps European clinical laboratories to perform nucleic acid preparation from plasma to facilitate compliance with IVD directives in their countries. The chemagic Plasma D2.0 Kit is intended for automated nucleic acid preparation from up to 2 ml serum or plasma. 24 samples can be processed at once in 60 minutes using chemagen´s robust and reliable automation – the Magnetic Separation Module I (MSM I). This machine was developed for automated nucleic acid isolation based on chemagen´s proprietary magnetic bead technology.

The principle is very efficient: Nucleic acids from serum/plasma bind to the surface of the patented Polyvinyl Alcohol (PVA) particles and can be further isolated automatically using the 24 magnetized rods of the chemagic 24 Rod Head. The DNA/RNA can be eluted either in TE, 10 mM Tris-HCl pH 8.0 or water. These high quality nucleic acids are ready to use for many downstream applications or disposed to long term storage.

Blood donation services and plasma fractionation facilities might be highly interested in this particular CE certified kit. The chemagic Plasma D2.0 Kit facilitates the viral screening of blood products. The validation of your entire diagnostic process is now simplified by using the chemagic Plasma D2.0 Kit for sample preparation. Additional CE IVD certified kits are currently in process.

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