Evacuated blood collection tube IVD, K2EDTA

An evacuated blood collection tube with K2EDTA is a sterile, single-use container made of glass or plastic that holds a pre-measured vacuum and the anticoagulant dipotassium EDTA. It is designed to collect, preserve, and transport whole blood samples for laboratory testing, including hematology, molecular diagnostics, and immunohaematology procedures such as blood typing and antibody screening.

Devices in this category are regulated as in vitro diagnostic medical devices and are supplied as single-use products intended for one-time patient contact. Their regulation depends on the intended use and jurisdiction, but they are universally classified as single-use and must meet sterility, biocompatibility, and performance requirements for blood specimen integrity.