IVD Department quantitative testing of Low Molecular Weight Heparin (LMWH) and Unfractionated Heparin (UFH) - Vietnam Registration 2402889ĐKLH/BYT-HTTB

1-2. The chromogenic anti-Xa assay method is used to quantitatively determine the concentration of FXa inhibitors in citrate-anticoagulated human blood plasma in vitro. This method is used to monitor patients treated with Heparin (UFH/LMWH), Arixtra®, Orgaran® and to support diagnosis by detecting the presence of resistance (Apixaban, Edoxaban, Rivaroxaban) in patients treated with anticoagulants. The in-vitro diagnostic device is intended for professional use in the laboratory. ; 3. It is used to calibrate the LMWH (Low Molecular Weight Heparin) and UFH (Unfractionated Heparin) assays when a cross-reactivity (LMWH/UFH) has been confirmed on the same calibration curve by the automated quantitative method. The in-vitro diagnostic device is intended for professional use in the laboratory. ; 4. It is used to calibrate the concentration of UFH (Unfractionated Heparin) by the automated quantitative method. The in-vitro diagnostic device is intended for professional use in the laboratory. ; 5-7. It is used to control the quality of the concentration of UFH (Unfractionated Heparin) by the automated quantitative method. The in-vitro diagnostic device is intended for professional use in the laboratory. ; 8-13. It is used to control the quality of the concentration of LMWH (Low Molecular Weight Heparin) by the automated quantitative method. The in-vitro diagnostic device is intended for professional use in the laboratory.