IVD Department Quantitative PAPP-A Testing - Vietnam Registration 2403592ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department Quantitative PAPP-A Testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403592ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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Device Details
Registration Details
2403592ĐKLH/BYT-HTTB
000.00.04.G18-240826-0001
Theo theo phụ lục
Theo phụ lục
Technical Details
Elecsys PAPP-A: An in vitro immunoassay for the quantitative determination of pregnancy-related plasma protein A in human serum. This test is used as a screening test to provide information in combination with other information to assess the risk of trisomy 21 (Down syndrome) in the first trimester of pregnancy. Further testing is required to diagnose abnormal chromosomal conditions. The fluorescent immunoassay "ECLIA" (electrochemiluminescence immunoassay "ECLIA") is used for the cobas e immunoassay analyzer. PAPP-A CalSet: The PAPP-A CalSet is used to calibrate the quantitative Elecsys PAPP-A immunoassay on the cobas e immunoassay analyzer.
Dates and Status
Nov 14, 2024