Vietnam MOH registration 2400670ĐKLH/BYT-HTTB

Drugs used for the Prothrombin Time (PT) blood clotting test

VN: Thuốc thử dùng cho xét nghiệm đông máu đo thời gian Prothrombin (PT)

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·DIAGNOSTICA STAGO S.A.S·Registered May 10, 2024

Registration details

Analysis ID: 2400670ĐKLH/BYT-HTTB
Submission ID: 17002936/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: DIAGNOSTICA STAGO S.A.S
Manufacturer Country: Theo theo phụ lục
Product Owner: DIAGNOSTICA STAGO S.A.S
Authorized Representative: CÔNG TY TNHH MEDIGROUP VIỆT NAM

Technical details

Intended Use: 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

Registration Date: May 10, 2024

About this record

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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