Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for the collection,stabilization, and transport of venous whole blood samples for use in conjunction with cell-free DNAnext- generation sequencing liquid biopsy assays that have been cleared or approved for use with samplescollected in the Cell-Free DNA BCT device.
A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant agent [e.g., tripotassium ethylene diamine tetraacetic acid (K3EDTA)], and a nucleic acid (DNA/RNA) stabilizer. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device.