Vietnam MOH registration 2300636ĐKLH/BYT-HTTB

Drug test for determining prothrombin time (PT) and quantifying fibrinogen

VN: Thuốc thử xét nghiệm xác định thời gian prothrombin (PT) và định lượng fibrinogen

Vietnam·Risk Class TTBYT Loại C·HemosIL ReadiPlasTin·Instrumentation Laboratory Company·Registered Jun 20, 2023

Registration details

Analysis ID: 2300636ĐKLH/BYT-HTTB
Submission ID: 17004867/ĐKLH-BYT-TB-CT
Product Type: HemosIL ReadiPlasTin
Product Code: 0020301400

Company information

Manufacturer: Instrumentation Laboratory Company
Manufacturer Country: UNITED STATES

Technical details

Intended Use: HemosIL ReadiPlasTin is a thromboplastin test, used in in vitro diagnosis, based on recombinant human tissue factor, and is used for the determination of prothrombin time (Prothrombin Time - PT) and quantification of fibrinogen in human plasma samples (anticoagulated with citrate), performed on the ACL TOP Family and ACL TOP Family 50 Series blood coagulation analyzers. The test is used to evaluate the extrinsic coagulation pathway and to monitor oral anticoagulant therapy with Vitamin K antagonists.

Dates and status

Registration Date: Jun 20, 2023

About this record

Access comprehensive regulatory information for Drug test for determining prothrombin time (PT) and quantifying fibrinogen 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 2300636ĐKLH/BYT-HTTB and manufactured by Instrumentation Laboratory Company.

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