Device typeEvacuated blood collection tube IVD, anticoagulant/separator: A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), sodium heparin, sodium citrate, potassium oxalate], and a separator (e.g., gel) to separate blood plasma from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., testing plasma in molecular diagnostics and viral load detection). This is a single-use device.
FDA categorySystem, Blood Collection, Vacuum-Assisted, Manual
Device ID00199874715100
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information