Vietnam MOH registration 2400829ĐKLH/BYT-HTTB

IVD Department Qualitative and Quantitative Testing of Rubella Virus-Specific IgG Antibodies

VN: Bộ IVD xét nghiệm định tính và định lượng kháng thể IgG kháng virus rubella

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Beckman Coulter, Inc.·Registered Jun 24, 2024

Registration details

Analysis ID: 2400829ĐKLH/BYT-HTTB
Submission ID: 17005354/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Beckman Coulter, Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Beckman Coulter, Inc.
Authorized Representative: CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG

Technical details

Intended Use: ACCESS RUBELLA IgG: The Access Rubella IgG test is a fluorescent immunoassay, based on the principle of chemiluminescence, to qualitatively and quantitatively determine the presence of IgG antibodies against the rubella virus in human serum using the Access Immunoassay Systems. The Access Rubella IgG test aids in the diagnosis of rubella infection and in determining the level of immunity. ACCESS RUBELLA IgG CALIBRATORS: Access Rubella IgG Calibrators are used to calibrate the Access Rubella IgG test for the qualitative and quantitative determination of IgG antibodies against the rubella virus in human serum using the Access Immunoassay Systems. ACCESS RUBELLA IgG QC: Access Rubella IgG QC is used to monitor the performance of the Access Rubella IgG test system.

Dates and status

Registration Date: Jun 24, 2024

About this record

Access comprehensive regulatory information for IVD Department Qualitative and Quantitative Testing of Rubella Virus-Specific IgG Antibodies 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 2400829ĐKLH/BYT-HTTB and manufactured by Beckman Coulter, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.

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