IVD Quantitative Thrombin Time Test Kit - Vietnam Registration 2401198ĐKLH/BYT-HTTB

1. Thromboclotin® is an in vitro diagnostic test used to determine the thrombin time, which aids in the diagnosis of disorders of blood coagulation associated with fibrinogen in patients with signs or at risk of bleeding, who are being anticoagulated with sodium citrate by various automated, semi-automated and/or manual coagulation methods. For the thrombin time test, there is no international reference preparation or method. ; 2. CONTROL N is a control material that has been tested and is used to evaluate the accuracy and precision of the following tests within the normal range: 1. Prothrombin Time (PT) 2. Activated Partial Thromboplastin Time (APTT) 3. Thrombin Time (TT) 4. Batroxobin Time 5. Fibrinogen 6. Factors II, V, VII, VIII, IX, X, XI, XII, XIII and vWF 7. Inhibitors: Antithrombin III, Protein C, Protein S, α2-Antiplasmin, C1 Inhibitor 8. Plasminogen 9. ProC Related Analytes 10. Lupus Anticoagulant. The reference values were determined at Siemens Healthcare Diagnostics Products GmbH using the Siemens Healthineers reagents on mechanical and optical coagulation systems. ; 3. Dade® Ci-Trol® 1 was specially developed as a control material for the normal range of blood coagulation tests with sodium citrate and is used to test the accuracy and precision on different test systems with the following applications: 1. Prothrombin Time (PT) 2. Activated Partial Thromboplastin Time (APTT) 3. Thrombin Time (TT) 4. Fibrinogen 5. Antithrombin III (ATIII) 6. Batroxobin/Reptilase Time The reference values were established on the optical and magnetic coagulation systems using the Siemens Healthineers reagents. The reference values were established with the reference standard international calibrator on blood samples that were citrated with sodium citrate.