Vietnam MOH registration 2402931ĐKLH/BYT-HTTB

IVD Department, Quantitative S-100B Testing

VN: Bộ IVD xét nghiệm định lượng S-100B

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Oct 22, 2024

Registration details

Analysis ID: 2402931ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-211124-0006
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: CÔNG TY TNHH THIẾT BỊ NHẬT ANH

Technical details

Intended Use: 1. LIAISON S100: LIAISON S100 is an in vitro fluorescent immunoassay (CLIA) used to quantify the concentration of S-100B protein in human serum and cerebrospinal fluid (CSF). LIAISON S100 is used to support the management of patients with melanoma. The test must be performed on the LIAISON automated immunoassay analyzer. 2. LIAISON S100 Cal (low/high): LIAISON S100 Cal (low/high) is used to calibrate the LIAISON S100 test. By measuring the calibration standards, the manufacturer's calibration curve is adjusted (re-calibrated) to a new, device-specific calibration curve after each calibration. Calibration standards are required to perform the LIAISON S100 test on the LIAISON automated immunoassay analyzer. 3. LIAISON Control S100: The LIAISON Control S100 (low and high) control materials are used in the fluorescent immunoassay (CLIA) LIAISON to assess the reliability of test runs. The performance characteristics of the LIAISON Control S100 control materials are not established for any other test or system other than the LIAISON and LIAISON XL automated immunoassay analyzers.

Dates and status

Registration Date: Oct 22, 2024

About this record

Access comprehensive regulatory information for IVD Department, Quantitative S-100B 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 2402931ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.

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