IVD Department for Blood Type Determination - Vietnam Registration 240002324/PCBA-HN

1. PeliControl (K1379) are whole blood samples that can be used as patient samples for quality control processes (internal control) for the following tests: ABO/Rh-D blood group determination, detection of abnormal antibodies and hemolytic reactions. 2. Cellbind direct type (K7012) is a column test to determine the blood group antigens on red blood cells, including red blood cells coated in vivo with the component antibodies and/or complement. 3. Cellbind LISS (K7110, 7130) is an in vitro diagnostic medical device for laboratory specialists, used to dilute red blood cells from EDTA blood samples into 0.5% suspension, which can be tested manually on the Cellbind column test card or in an automated analyzer. 4. Cellbind P3 (K7210), Cellbind ID16 (K7230) are 0.5% cell suspension for screening and identification of red blood cell antibodies in human serum and plasma. 5. Cellbind A1 reagent red cells (K7240), Cellbind B reagent red cells (K7242): These 0.5% cell suspensions are recommended for use in the Cellbind Screen card (see the K7000 User Manual) to detect anti-A and anti-B antibodies (A1 and B test cells) in human serum or plasma and are used as positive and negative controls (O positive cells and A2 test cells). 6. Stirrer Balls (K7390) are stirrer balls used in the blood group determination test, to prevent the aggregation of red blood cells in the test. 7. Pelikloon anti-E (lgM) monoclonal (K1191, K1204), Pelikloon anti-C (IgM) monoclonal (K1195, K1202), Pelikloon anti-c (IgM) monoclonal (K1196, K1203), Pelikloon anti-e (IgM) monoclonal (K1197, K1205): Blood group reagents to detect the Rh E, C, c, or e antigens on human red blood cells. 8. Pelikloon anti-K (IgM) monoclonal (K1199): Blood group reagents to detect the Kell (K) antigen on human red blood cells. 9. Cellbind Workstation (K7301): The Cellbind sample tray, where the reaction takes place. 10. Cellbind Centrifuge (12 cards) (K7312): The Cellbind centrifuge, pre-programmed to work with the Cellbind column test cards. 11. Cellbind incubator (K7314): The Cellbind incubator, used to incubate the Cellbind column test cards. 12. Cellbind DILUENT (K7180): The LISS buffer solution for the Cellbind column test cards, the diluent medium to prepare the 0.5% red blood cell suspension from Sanquin 3% red blood cells or Sanquin red blood cell suspension (100 ml).