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Drug test for determining prothrombin time (PT) and quantifying fibrinogen - Vietnam Registration 2300636ĐKLH/BYT-HTTB

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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2300636ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2300636ĐKLH/BYT-HTTB
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Device Details

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
Risk Class TTBYT Loại C

Registration Details

2300636ĐKLH/BYT-HTTB

17004867/ĐKLH-BYT-TB-CT

HemosIL ReadiPlasTin

0020301400

Company Information

UNITED STATES

Technical Details

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

Jun 20, 2023