Drugs used for the Prothrombin Time (PT) blood clotting test - Vietnam Registration 2400670ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Drugs used for the Prothrombin Time (PT) blood clotting test 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 2400670ĐKLH/BYT-HTTB and manufactured by DIAGNOSTICA STAGO S.A.S. The authorized representative in Vietnam is CÔNG TY TNHH MEDIGROUP VIỆT NAM.
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Device Details
Registration Details
2400670ĐKLH/BYT-HTTB
17002936/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
The STA® - NeoPTimal kit provides a thromboplastin extracted from rabbit brain, to determine the prothrombin time (PT), in citrated human blood (3.2% sodium citrate), on the STA-R®, STA Compact® and STA Satellite machines. STA® - NeoPTimal is a blood coagulation screening test used by clinical laboratories to assess the extrinsic coagulation process and to monitor the treatment of oral anticoagulation with vitamin K antagonists, using the International Normalized Ratio (INR).
Dates and Status
May 10, 2024