IVD Department quantitative fibrinogen testing
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Siemens Healthineers·Registered Nov 02, 2024- Analysis ID
- 2403238ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-230314-0021
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Siemens Healthineers
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Siemens Healthineers
- Authorized Representative
- CÔNG TY TNHH SYSMEX VIỆT NAM
- Intended Use
- 1,2 - Multifibren® U is an in vitro diagnostic test to quantify fibrinogen and is used to diagnose congenital or acquired fibrinogen disorders, or to monitor patients with bleeding disorders or a risk of fibrinogen deficiency in their blood, using various automated and manual hemostasis measurement methods. The determination of fibrinogen by Multifibren® U is standardized based on the reference methods of Ratnoff Menzie and Kjeldahl. In addition, Multifibren® U can be used to support the diagnosis and monitoring of fibrinogen consumption in patients at risk or showing signs of disseminated intravascular coagulation (DIC). ; 3 - The CALIBRATOR 1 to CALIBRATOR 6 are used to establish the reference curve for the fibrinogen test using the Clauss method with Siemens Healthcare Diagnostics Multifibren® U. ; 4 - Dade® Ci-Trol® 1 is specially developed as a control material for the normal range of blood coagulation tests with sodium citrate anticoagulation and is used to assess the accuracy and precision of 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 values are established on the Siemens Healthcare Diagnostics Products GmbH system using the Siemens Healthineers test reagents and are based on the reference values obtained from the International Standard Reference Material on blood samples anticoagulated with sodium citrate. ; 5 - CONTROL P is a control material that has been tested and is used to evaluate the accuracy and precision of the following tests in the pathological range: 1. Prothrombin Time (PT) 2. Activated Partial Thromboplastin Time (APTT) 3. Fibrinogen (Clauss method) 4. Factors II, V, VII, VIII, IX, X, XI, XII, XIII and vWF 5. Inhibitors: Antithrombin III, Protein C, Protein S, α2-Antiplasmin, C1 Inhibitor 6. Plasminogen 7. Thrombin Time (a) The values are determined by the Siemens Healthineers test reagents on the mechanical and optical coagulation systems. (a) The applications and reference values may differ in different countries. ; 6 - CONTROL N is a control material that has been tested and is used to evaluate the accuracy and precision of the following tests in the normal range: 1. Prothrombin Time (PT) 2. Activated Partial Thromboplastin Time (APTT) 3. Thrombin Time (TT) 4. Batroxobin/Reptilase 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 values are determined by the Siemens Healthineers test reagents on the mechanical and optical coagulation systems at Siemens Healthcare Diagnostics Products GmbH.
- Registration Date
- Nov 02, 2024
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