Vietnam MOH registration 2403590ĐKLH/BYT-HTTB

The IVD Quantitative Tyrosine Kinase-1 Assay of the fms-like Form

VN: Bộ IVD xét nghiệm định lượng tyrosine kinase-1 dạng hòa tan tương tự fms

Vietnam·Risk Class TBYT Loại C·Theo theo phụ lục·Siemens Healthcare Diagnostics Products Ltd·Registered Nov 14, 2024

Registration details

Analysis ID: 2403590ĐKLH/BYT-HTTB
Submission ID: 18007776/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Siemens Healthcare Diagnostics Products Ltd
Manufacturer Country: Theo theo phụ lục
Product Owner: Siemens Healthcare Diagnostics Products Ltd
Authorized Representative: CÔNG TY TNHH SIEMENS HEALTHCARE

Technical details

Intended Use: - Atellica IM sFlt-1: The Atellica IM Soluble fms-like Tyrosine Kinase-1 (sFlt-1) test is used for in vitro diagnosis to quantify the concentration of the soluble form of fms-like tyrosine kinase-1 (sFlt-1) in human plasma and serum (K2 EDTA) using the Atellica IM Analyzer and Atellica CI Analyzer. The Atellica IM sFlt-1 test is used in combination with the Atellica IM PlGF test to determine the sFlt-1/PlGF ratio (PE ratio). The PE ratio is used as a predictive marker for preterm birth and adverse outcomes in women with signs and symptoms of preeclampsia. - Atellica IM sFlt-1 QC: The AtellicaIM sFlt-1 Quality Control (sFlt-1QC) test is used for in vitro diagnosis to monitor the accuracy and precision of the AtellicaIM sFlt-1 test.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for The IVD Quantitative Tyrosine Kinase-1 Assay of the fms-like Form in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403590ĐKLH/BYT-HTTB and manufactured by Siemens Healthcare Diagnostics Products Ltd. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.

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