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Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for the collection, and transport of venous whole blood samples for use in conjunction with cell-free DNA next-generation sequencing liquid biopsy assays that have been cleared or approved for use with samples collected in the Cell-Free DNA BCT device.

Cell-Free DNA BCT is a sterile, single use, direct-draw blood collection tube comprised of 3 components (i.e. glass tube with rubber stopper, anticoagulant, and cell preservatives). The blood collection tube manufactured with USP Type III glass containing cerium oxide (to prevent color change associated with gamma irradiation). Each tube includes 200 uL ± 10% of liquid reagent composition includes an anticoagulant K3EDTAand a preservative. The device is intended to be placed inside a tube holder or an adaptor that contains a needle designed to pierce the tube closure and allow blood to flow into the tube. Once the vein has been penetrated blood collection needle or a blood collection set), the tube is pushed into the holder, and the blood enters the tube. Once a tube has drawn the appropriate amount of blood (10 mL), it is disengaged from the holder and inverted 10 times to mix the blood. The specimen is then transported to the lab for plasma isolation and extraction of cfDNA.