Vietnam MOH registration 2403236ĐKLH/BYT-HTTB

IVD Department quantitative test for the activity of Protein C (APC)

VN: Bộ IVD xét nghiệm định lượng khả năng kháng Protein C hoạt hóa (APC)

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Siemens Healthineers·Registered Nov 02, 2024

Registration details

Analysis ID: 2403236ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230314-0027
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Siemens Healthineers
Manufacturer Country: Theo theo phụ lục
Product Owner: Siemens Healthineers
Authorized Representative: CÔNG TY TNHH SYSMEX VIỆT NAM

Technical details

Intended Use: 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

Registration Date: Nov 02, 2024

About this record

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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