IVD Department Quantitative Free PSA Testing - Vietnam Registration 2400889ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2400889ĐKLH/BYT-HTTB
000.00.04.G18-211007-0015
Theo theo phụ lục
Theo phụ lục
Technical Details
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.
Dates and Status
Jun 24, 2024