Immunohematology

A Blood Grouping Kit is a Class II medical device (FDA-cleared/CE-marked) containing monoclonal antibodies (Anti-A, Anti-B, Anti-D) and control reagents for determining ABO blood group and Rh factor by agglutination method. The kit includes color-coded reagent vials, reaction cards or slides, mixing sticks, lancets, and capillary pipettes. Test time 2-5 minutes (slide method) or 15-30 minutes (tube method). Interpretation based on agglutination pattern: Anti-A positive = group A; Anti-B positive = group B; both positive = group AB; both negative = group O; Anti-D positive = Rh positive; Anti-D negative = Rh negative. Primary clinical applications include pre-transfusion compatibility testing, prenatal and neonatal testing (Rh incompatibility prevention), preoperative blood typing, blood donor screening, and emergency blood typing. Critical safety precautions include refrigerated storage (2-8°C), proper disposal of lancets in sharps containers, universal precautions for blood samples, and confirmation with reverse typing when possible. Essential kit for transfusion medicine, obstetrics, surgery, and emergency care.