IVD Department quantitative test for the activity of Protein C (APC) - Vietnam Registration 2403236ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department quantitative test for the activity of Protein C (APC) 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 2403236ĐKLH/BYT-HTTB and manufactured by Siemens Healthineers. The authorized representative in Vietnam is CÔNG TY TNHH SYSMEX VIỆT NAM.
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Device Details
Registration Details
2403236ĐKLH/BYT-HTTB
000.00.04.G18-230314-0027
Theo theo phụ lục
Theo phụ lục
Technical Details
Quantitative testing used in vitro for the diagnosis of activated protein C resistance (APCR) based on the activity of the Russell's viper venom toxin inhibitor to support the diagnosis and screening of the inherited factor V Leiden (FVL) mutation in patients with thrombosis or at risk for APCR in human blood plasma with sodium citrate as an anticoagulant using automated blood coagulation methods. For APCR testing, there are no international references for the method or preparation protocol.
Dates and Status
Nov 02, 2024