IVD Department Qualitative IgM Antibody Test for Rubella Virus
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered May 10, 2024- Analysis ID
- 2400636ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-210323-0004
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- CÔNG TY TNHH ROCHE VIỆT NAM
- Intended Use
- Elecsys Rubella IgM: An in vitro immunoassay for the qualitative determination of IgM antibodies against the Rubella virus in human serum and plasma. The ECLIA (Electrochemiluminescence Immunoassay) is used on Elecsys and cobas e immunoassay analyzers. PreciControl Rubella IgM: PreciControl Rubella IgM is used to control the quality of the Elecsys Rubella IgM immunoassay on the cobas e immunoassay analyzer.
- Registration Date
- May 10, 2024
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Access comprehensive regulatory information for IVD Department Qualitative IgM Antibody Test for Rubella Virus 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 2400636ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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