Vietnam MOH registration 2401199ĐKLH/BYT-HTTB

IVD Department quantitative test for activated partial thromboplastin time (APTT)

VN: Bộ IVD xét nghiệm định lượng thời gian thromboplastin từng phần hoạt hóa (APTT)

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

Registration details

Analysis ID: 2401199ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220927-0020
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: 1-2. Pathromtin® SL is an in vitro diagnostic test drug used to quantitatively assess the activated partial thromboplastin time (APTT) in the diagnosis, screening of bleeding disorders and monitoring of unfractionated heparin in human blood plasma, using automated, semi-automated and/or manual coagulation analyzers. There is no international reference preparation or method for APTT testing. ; 3. Dade® Ci-Trol® 1 was specially developed as a control material for the reference limit of coagulation tests with sodium citrate as the anticoagulant and is used to assess the accuracy and precision of different coagulation 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 Siemens Healthineers' photometric and spectroscopic coagulation analyzers using the Siemens Healthineers' test reagents. The reference values were established with the International Standard Reference Material on blood plasma samples that were anticoagulated with sodium citrate. ; 4. Dade® Ci-Trol® 2 was specially developed as a control material for the intermediate to high range of the therapeutic limit of oral anticoagulation. By inactivating the factors FII, FVII, FIX and FX, this control material is equivalent to the blood of patients treated with oral anticoagulants. Dade® Ci-Trol® 2 is introduced into the test as an abnormal blood sample to control accuracy and precision. In addition to the reference value for the prothrombin time (PT), Dade® Ci-Trol® 2 also provides the reference value for the activated partial thromboplastin time (APTT) to monitor the reduction in the activity of the endogenous clotting factors as well as the therapeutic limit in heparin therapy. The reference values were established on the Siemens Healthineers' photometric and spectroscopic coagulation analyzers using the Siemens Healthineers' test reagents. The reference values were established with the International Standard Reference Material on blood plasma samples that were anticoagulated with sodium citrate. ; 5. Dade® Ci-Trol® 3 was specially developed as a control material for the high range of the therapeutic limit of oral anticoagulation. By inactivating the factors FII, FVII, FIX and FX, this control material is equivalent to the blood of patients treated with oral anticoagulants. Dade® Ci-Trol® 3 is introduced into the test as an abnormal blood sample to control accuracy and precision. In addition to the reference value for the prothrombin time (PT), Dade® Ci-Trol® 3 also provides the reference value for the activated partial thromboplastin time (APTT) to monitor the reduction in the activity of the endogenous clotting factors as well as the therapeutic limit in heparin therapy. The reference values were established on the Siemens Healthineers' photometric and spectroscopic coagulation analyzers using

Dates and status

Registration Date: Aug 14, 2024

About this record

Access comprehensive regulatory information for IVD Department quantitative test for activated partial thromboplastin time (APTT) 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 2401199ĐKLH/BYT-HTTB and manufactured by Siemens Healthineers. The authorized representative in Vietnam is CÔNG TY TNHH SYSMEX VIỆT NAM.

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