Vietnam MOH registration 2401198ĐKLH/BYT-HTTB

IVD Quantitative Thrombin Time Test Kit

VN: Bộ IVD xét nghiệm định lượng thời gian thrombin

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Siemens Healthineers·Registered Aug 14, 2024

Registration details

Analysis ID: 2401198ĐKLH/BYT-HTTB
Submission ID: 19010890/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Siemens Healthineers
Manufacturer Country: Theo theo phụ lục
Product Owner: Siemens Healthineers
Authorized Representative: CÔNG TY TNHH SYSMEX VIỆT NAM

Technical details

Intended Use: 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.

Dates and status

Registration Date: Aug 14, 2024

About this record

Access comprehensive regulatory information for IVD Quantitative Thrombin Time Test Kit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2401198ĐKLH/BYT-HTTB and manufactured by Siemens Healthineers. The authorized representative in Vietnam is CÔNG TY TNHH SYSMEX VIỆT NAM.

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