The PAXgene Blood DNA Tube (IVD) is intended to collect, anticoagulate, stabilize, transport, and store a venous whole blood sample for preparation of human DNA for use with molecular diagnostic test methods that require DNA. The performance characteristics of this device have not been established for molecular diagnostic assays in general. Users must validate the use of a product for their specific molecular diagnostic assay. The intended use and claims have been validated with the QIAamp DSP DNA Blood Mini Kit (IVD) and the QIAsymphony DSP DNA Kit (IVD).