IVD Department Quantitative Free PSA Testing
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Jun 24, 2024- Analysis ID
- 2400889ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-211007-0015
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- CÔNG TY TNHH THIẾT BỊ NHẬT ANH
- Intended Use
- LIAISON fPSA: The LIAISON fPSA in vitro test is used to quantify the concentration of free prostate-specific antigen (fPSA) in human serum and plasma samples (anticoagulated with heparin or EDTA). It is performed only on the LIAISON automated immunoassay instrument. LIAISON Control fPSA: The LIAISON Control fPSA (low and high level) controls are used in the LIAISON fPSA CLIA test to monitor the reliability of individual test runs. The performance characteristics of the LIAISON Control fPSA controls are not established for any other test or system except the LIAISON and LIAISON XL automated immunoassay instruments.
- Registration Date
- Jun 24, 2024
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Access comprehensive regulatory information for IVD Department Quantitative Free PSA 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 2400889ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.
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