Products
What will AGI do for Automated coombs test systems?
In this classification, an automated Coombs test system is a device used to detect and identify antibodies in patient sera or antibodies bound to red cells. The Coombs test is used for the diagnosis of hemolytic disease of the newborn, and autoimmune hemolytic anemia. The test is also used in cross matching and in investigating transfusion reactions and drug-induced red cell sensitization. US FDA regulates Automated coombs test systems under 21 CFR 864.9300 and under FDA product code KSM.