The PAXgene Blood ccfDNA Tube (CE-IVD) with the QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD) and the QIAGEN QIAsymphony instrument (CE-IVD) have been verified and validated as an integrated CE-IVD compliant workflow. The QIAsymphony PAXgene Blood ccfDNA (CE-IVD) system is the first collection-through-extraction CE-IVD compliant workflow for ccfDNA.
In addition, we have received the In Vitro Diagnostic (IVD) EU Quality Management System (QMS) Certificate according to ISO 13485 and compliance to the new EU IVDR 2017/746 for In Vitro Diagnostic Medical Devices (IVDR) for PAXgene Blood Collection Tubes (CE-IVD) and QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD).
The QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD) is revolutionizing blood sample processing for ccfDNA extraction. The complete system consists of:
The QIAsymphony PAXgene Blood ccfDNA (CE-IVD) system provides a streamlined, CE-IVD compliant workflow for extracting ccfDNA:
By not using secondary tubes, you significantly lower costs and reduce biohazardous waste by almost 80%. Without the need for sample transfer, you minimize the risk of sample misidentification and blood exposure. Ultimately, by processing primary blood collection tubes, you save time, money and resources, while reducing waste and the potential for error. The QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD) – simplifying your blood sample processing, increasing your productivity.
QIAsymphony PAXgene Blood ccfDNA (CE-IVD) system provides flexibility in the sample volumes you choose to process. PAXgene Blood ccfDNA Tube (CE-IVD) handling protocols are available for sample input volumes of 2.4 ml and 4.0 ml plasma. Compared to processing methods requiring secondary tubes, the QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD) provides consistent and comparable high ccfDNA yields.
Download our Technical NoteWith the new QIAsymphony PAXgene Blood ccfDNA (CE-IVD) system you can save time and resources, while reducing waste and costs. The CE-IVD compliant collection-through-extraction workflow for extracting ccfDNA provides flexibility in sample volumes without sacrificing performance. Explore the QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD) and see how it can improve your blood sample processing for ccfDNA extraction.
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