Vietnam MOH registration 2403595ĐKLH/BYT-HTTB

IVD Department quantitative HER-2/neu testing

VN: Bộ IVD xét nghiệm định lượng HER-2/neu

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Nov 14, 2024

Registration details

Analysis ID: 2403595ĐKLH/BYT-HTTB
Submission ID: 18007778/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: CÔNG TY TNHH SIEMENS HEALTHCARE

Technical details

Intended Use: - Atellica IM H2n: The Atellica IM Her-2/neu (H2n) test is used for in vitro diagnosis to quantify the amount of HER-2/neu protein in human blood serum using the Atellica IM Analyzer and Atellica CI Analyzer. Values of HER-2/neu obtained in the monitoring and surveillance of patients with metastatic breast cancer, who have an initial concentration of HER-2/neu in serum > 15 ng/mL, can be used. It is recommended to use the values of HER-2/neu in combination with clinical diagnosis information and other diagnostic procedures in the management of breast cancer. The clinical benefit of the serum HER-2/neu measurement as a predictive indicator of early recurrence and in the management of patients with immune therapy has not been fully established. This test should be performed at the request of the physician. It should not be performed on any other system. - Atellica IM H2n CAL: The Atellica IM HER-2/neu Calibrator (H2n CAL) is used for in vitro diagnosis to calibrate the Atellica IM H2n test using the Atellica Immunoassay Analyzer. - Atellica IM H2n QC: The Atellica IM HER-2/neu Quality Control (H2n QC) is used for in vitro diagnosis to monitor the accuracy and precision of the Atellica IM H2n test using the Atellica Immunoassay Analyzer.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for IVD Department quantitative HER-2/neu testing 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 2403595ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.

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